Substantially Equivalent 510(k) Device Information
This list includes cleared 510(k) submissions for which we have supporting documents available, and reflects the information as of the clearance date. It is not updated with regard to applicant or application status changes.
Complete List of Currently Cleared 510(k) Submissions.
Information is arranged in alphabetical order by the name of the applicant.
Applicant | 510K Number | Product | Date |
---|---|---|---|
AbSorber AB Sweden |
BK070011 | XM-ONE Transplantation Cross Match | 7/29/2008 |
AcroMetrix Corp Benicia, CA |
BK060064 | VeriSure Pro HBV DNA External Quality Control | 2/8/2007 |
AcroMetrix Corp Benicia, CA |
BK050061 | VeriSure Pro West Nile Virus (WNV) RNA External Quality Controls: VeriSure Pro WNV RNA Negative External Quality Control VeriSure Pro WNV RNA Positive External Quality Control |
12/21/2005 |
Activated Cell Therapy, Inc Mountain View, CA |
BK960002 | ACT Buoyant Density Solution | 8/12/1996 |
Alba Bioscience United Kingdom |
BK080051 | FETALSCREEN™ II | 4/8/2009 |
Alba Bioscience United Kingdom |
BK080027 | ALBAcheck - BGS Reagent Control for Anti-D | 7/29/2008 |
Alba Bioscience United Kingdom |
BK070033 | AlbaQ-Chek Simulated Whole Blood Controls | 7/27/2007 |
Alpha Scientific Corp Southeastern, PA |
BK940054 | SEG-SAFE | 3/15/1995 |
Alpha Therapeutic Corp City of Industry, CA |
BK950044 | Transfer Device | 10/18/1995 |
American Blood Resources Association Annapolis, MD |
BK010012 | National Donor Deferral Registry (NDDR) 1.0 | 8/30/2001 |
American Blood Resources Association Annapolis, MD |
BK960030 | National Donor Deferral Registry | 3/20/1997 |
American Red Cross Blood Services Arlington, VA |
BK20032 | NGTL Automation System (NAS) 5.2.0 | 3/20/2003 |
Applied Biosystems / Celera Diagnostics Alameda, CA 94502 |
BK030005 | ViroSeq HIV-1 Genotyping System with the 3100 Genetic Analyzer | 1/29/2003 |
Applied Science, Inc Grass Valley, CA 95945 |
BK010031 | Hemoflow Model 400 with Data Scanner | 1/23/2002 |
Arlington Scientific, Inc Springville, UT 84663 |
BK020031 | ASI TPHA Test | 1/30/2003 |
Arthrex Incorporated Naples , FL 34108 |
BK070069 | Arthrex Double Syringe (ACP, Autologous Conditioned Plasma) System | 12/12/2008 |
Baxter Healthcare Corp McGaw Park, IL |
BK060061 | ALYX Component Collection System: ALYX 2RBC-NLR Kit | 2/9/2007 |
Baxter Healthcare Corp McGaw Park, IL |
BK050038 | AMICUS Separator System | 11/3/2005 |
Baxter Healthcare Corp Round Lake, IL |
BK040084 | ALYX Component Collection System | 3/15/2005 |
Baxter Healthcare Corp - Transfusion Therapies Division Round Lake, IL |
BK040059 | Amicus Separator System | 9/24/2004 |
Baxter Healthcare Corp Round Lake, IL |
BK020059 | ALYX Component Collection System | 1/23/2003 |
Baxter Healthcare Corp Round Lake, IL |
BK020056 | ALYX System | 12/20/2002 |
Baxter Healthcare Corp Round Lake, IL |
BK020008 | LeukoConnect | 12/16/2002 |
Baxter Healthcare Corp Round Lake, IL |
BK010033 | Cygnet System | 8/27/2002 |
Baxter Healthcare Corp Round Lake, IL |
BK000039 | Amicus Separator, Concurrent Collection of Red Blood Cells | 8/26/2002 |
Baxter Healthcare Corp Round Lake, IL |
BK000047 | Amicus Separator, Mononuclear Cell Collection | 7/31/2002 |
Baxter Healthcare Corp Round Lake, IL |
BK990009 | Fenwal Amicus Separator Collection of Three Platelet Products | 3/3/2000 |
Baxter Healthcare Corp Round Lake, IL |
BK980041 | Sepacell Pre-Storage Leukocyte Set for Red Cells | 7/16/1999 |
Baxter Healthcare Corp Round Lake, IL |
BK940009 | Optipress Automated Blood Component Extractor | 5/18/1994 |
Baxter Healthcare Corp Round Lake, IL |
BK920003 | Fenwal Needle/Tube Sampling Protector and Needle Safety Cover | 3/12/1992 |
BBI Diagnostics West Bridgewater, MA 02379 |
BK060030 | ACCURUN 804 Nucleic Acid Negative Quality Control (HIV, HCV, HBV, WNV) | 8/18/2006 |
BBI Diagnostics West Bridgewater, MA 02379 |
BK060022 | ACCURUN 365 West Nile Virus RNA Positive Quality Control | 6/12/2006 |
BD Biosciences San Jose, CA 95131-1807 |
BK050073 | BD HLA-B27 System | 2/16/2006 |
BD Biosciences San Jose, CA 95131-1807 |
BK050062 | BD HLA-B27 kit | 10/27/2005 |
BD Biosciences San Jose, CA 95131-1807 |
BK030027 | BD IMAGN Microvolume Fluorimeter and BD IMAGN rWBC Assay Kit | 7/10/2003 |
Beckman Coulter, Inc Miami, FL 33196-2500 |
BK040055 | stemCXP System for the FC 500 with CXP Software | 9/16/2004 |
Beckman Coulter, Inc Miami, FL 33196-2500 |
BK040032 | Stem-Kit Reagents | 5/5/2004 |
Beckman Coulter, Inc Miami, FL 33196-2500 |
BK020063 | LeukoSure Enumeration Kit with Leuko-Trol RBC Control Cells and Leuko Trol Platelet Control Cells | 2/3/2003 |
Beckman Coulter, Inc Miami, FL 33196-2500 |
BK010044 | stemONE System for EPICS XL/XL-MCL Flow Cytometry Systems | 5/20/2002 |
Becton, Dickinson & Company Franklin Lakes, NJ 07417-1885 |
BK060046 | Bd.id Patient Identification System for Transfusion Management V7.00 | 2/13/2007 |
Becton, Dickinson & Company Franklin Lakes, NJ 07417-1885 |
BK050036 | BD Vacutainer SST II Advance Tubes; BD Vacutainer Plus K2EDTA Tubes; BD Vacutainer Plus Serum Tubes; BD Vacutainer SST Glass Tubes; BD Vacutainer SST Plus Tubes | 2/24/2006 |
Becton, Dickinson & Company Franklin Lakes, NJ 07417-1885 |
BK040030 | BD Vacutainer Plus Plastic Serum Tubes with Clot Activator | 5/5/2004 |
Becton Dickinson Vacutainer Systems Franklin Lakes, NJ 07417 |
BK980011 | VACUTAINER Brand PLUS (Plastic) Blood Collection Tube with EDTA Anticoagulant | 6/7/1999 |
BioErgonomics, Inc St. Paul, MN |
BK000046 | FluoroTrol Control Kits | 4/2/2001 |
BioLife Plasma Services LP Deerfield IL |
BK060017 | Donor Information System (DIS) 3.2 | 5/9/2006 |
BioLife Plasma Services LP Deerfield IL |
BK050029 | Donor Information System (DIS) 3.1 | 7/7/2005 |
BioMerieux, Inc Durham, NC 27712 |
BK050037 | BacT/ALERT BPA Culture Bottle | 12/27/2005 |
BioMerieux, Inc Durham, NC 27712 |
BK050043 | BacT/ALERT BPN Culture Bottle | 12/27/2005 |
BioMerieux, Inc Durham, NC 27712 |
BK030076 | BacT/ALERT BPA Culture Bottles | 3/8/2004 |
BioMerieux, Inc Durham, NC 27712 |
BK030075 | BacT/ALERT BPN Culture Bottles | 3/8/2004 |
BioMerieux, Inc Durham, NC 27712 |
BK030034 | BacT/ALERT BPN Culture Bottle | 7/18/2003 |
BioMerieux, Inc Durham, NC 27712 |
BK020022 | BacT/ALERT SN Culture Bottle | 10/10/2002 |
BioMerieux, Inc Durham, NC 27712 |
BK020023 | BacT/ALERT SA Culture Bottle | 10/10/2002 |
BioMerieux, Inc Durham, NC 27712 |
BK000042 | BacT/ALERT Culture Bottles | 2/15/2002 |
Biomet Biologics, Incorporated Warsaw, IN |
BK080004 | Clotalyst and GPS III Platelet Concentrate Separation Kit with ACD-A, Clotalyst and GPS III Mini Platelet Concentrate Separation Kit with ACD-A |
12/19/2008 |
Biomet,Inc. Warsaw, IN |
BK050016 | GPS II Platelet Concentrate Separation Kit w/ Plasma Concentrator Accesory | 7/20/2005 |
Biomet,Inc. Warsaw, IN |
BK040036 | GPS II Platelet Concentrate Separation Kit | 6/24/2004 |
Biometric Imaging, Inc Mountain View, CA |
BK970015 | CEQer RBC Assay | 9/18/1998 |
Biometric Imaging, Inc Mountain View, CA |
BK970016 | CEQer PRP Assay | 9/18/1998 |
Biometric Imaging, Inc Mountain View, CA |
BK970018 | STELLer CD34 Assay | 8/18/1998 |
Biosafe SA Alexandria, VA |
BK060036 | Sepax Cell Separation System and single use kits | 1/3/2007 |
Biotest AG Germany |
BK060066 | TANGO Automated Blood Bank Analyzer System, Version 3.0 Service Pack 4 | 1/17/2007 |
Biotest Medical Diagnostics GmbH Germany |
BK080013 | Alsever’s Solution (510(k) exempt but part of system) Solidscreen II Control B Solidscreen Negative Control Tango Optimo Automated Blood Bank Analyzer System with version 3.1 |
7/23/2008 |
Biotest Medical Diagnostics GmbH Germany |
BK080012 | Seraclone Control ABO+Rh; Coombscell-E; MLB2 | 7/23/2008 |
Biotest Diagnostics Corp Denville, NJ |
BK960061 | Biotest DQB-ELPHA | 8/4/1997 |
Biotest Diagnostics Corp Denville, NJ |
BK960086 | Biotest High Resolution Supplementary Kit | 7/3/1997 |
Blackhawk BioSystems, Inc San Ramon CA |
BK060052 | AmpliTrol III | 11/7/2006 |
Blood Bank Computer Systems, Inc Auburn, WA |
BK040087 | BBCS Lab Interface Application (BBCS Lab) 5.0L | 2/15/2005 |
Blood Bank Computer Systems, Inc Auburn, WA |
BK040056 | Blood Bank Control System (BBCS) 5.0 | 10/22/2004 |
Boston Biomedica, Inc West Bridgewater, MA |
BK040016 | ACCURUN 305 HCV RNA Positive Quality Control | 12/17/2004 |
Boston Biomedica, Inc West Bridgewater, MA |
BK040067 | ACCURUN 803 Nucleic Acid Negative Quality Control (HIV, HCV, HBV) | 11/19/2004 |
Boston Biomedica, Inc West Bridgewater, MA |
BK040064 | ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150 | 10/29/2004 |
Boston Biomedica, Inc West Bridgewater, MA |
BK040006 | ACCURUN 315 HIV-1 RNA Positive Control | 10/12/2004 |
Boston Biomedica, Inc West Bridgewater, MA |
BK990032 | Accurun 106 HIV-1 Antigen | 1/20/2000 |
Care Fusion, Inc. McLean, VA |
BK040002 | wBlood Care 1.0 | 11/10/2004 |
CaridianBCT, Inc. Lakewood , CO |
BK080043 | Atreus Whole Blood Processing System | 9/29/2008 |
CaridianBCT, Inc. Lakewood , CO |
BK080035 | Trima Accel Automated Blood Component Collection System, COBE Spectra Apheresis System | 8/29/2008 |
Cascade Medical Enterprises, LLC Wayne, NJ |
BK020051 | Cascade Medical Fibrinet, Autologous Platelet System | 12/20/2002 |
Celera Diagnostics Alameda, CA |
BK030033 | ViroSeq HIV-1 Genotyping System with the 3700 Genetic Analyzer | 6/11/2003 |
Celera Diagnostics/Applied Biosystems, Inc Alameda, CA |
BK010024 | ViroSeq HIV-1 Genotyping System | 12/10/2002 |
Cerner Corporation Kansas City, MO |
BK060037 | Cerner Bridge Medical Transfusion Administration and Specimen Collections 3.3 | 5/24/2007 |
Cerner Corporation Kansas City, MO |
BK030028 | Cerner Millennium PathNet Blood Bank Donor (PA-22200) 2003.01 | 8/19/2003 |
Charter Medical, Ltd Winston-Salem NC |
BK050021 | Charter Medical Transfer Set | 7/22/2005 |
Charter Medical, Ltd Winston-Salem NC |
BK060042 | Cell Freeze Liquid Nitrogen Freezing Container | 10/3/2008 |
Chiron Corporation Emeryville, CA |
BK060005 | Chiron Procleix NAT Tracker 3.0 | 3/1/2006 |
Chiron Corporation Emeryville, CA |
BK050004 | Procleix Optiva RAS | 4/8/2005 |
COBE Cardiovascular, Inc Arvada, CO |
BK050033 | COBE Angel Whole Blood Separation System | 8/22/2005 |
COBE BCT Lakewood, CO |
BK990025 | COBE Trima | 4/7/2000 |
COBE BCT Lakewood, CO |
BK970005 | Focussed System | 10/13/1998 |
Community Bio-Resources, Inc Hoover, AL |
BK970007 | Donor Information System, Version 1.0 | 4/9/1997 |
Cytomedix, Inc Rockville, MD |
BK060007 | AutoloGel System | 9/20/2007 |
CytoTherm Trenton, NJ |
BK080019 | CytoTherm Plasma Thawing System | 7/16/2008 |
CytoTherm LP Trenton, NJ |
BK060027 | CytoTherm Plasma Thawing System | 8/1/2006 |
Data Innovations, Inc South Burlington, VT |
BK060053 | Instrument Manager 8.05.01.10 | 1/5/2007 |
Data Innovations, Inc.. South Burlington, VT |
BK020057 | imExpress 7.2.5 | 7/29/2003 |
DENCO, Inc Wilmington, DE |
BK000022 | Total Containment Device | 4/18/2000 |
DENCO, Inc Wilmington, DE |
BK990041 | Total Containment Device TCD | 12/21/1999 |
Department of Veterans Affairs Hines IL |
BK060043 | VistA Blood Establishment Computer Software (VBECS) 1.0 | 10/19/2006 |
Digi-Trax Corp Buffalo Grove, IL |
BK010049 | Donor-ID 2.2 | 4/26/2002 |
Digi-Trax Corp Buffalo Grove, IL |
BK000020 | Digi-Trax Donor-ID 2.0 | 4/20/2000 |
Digi-Trax Corp Buffalo Grove, IL |
BK970013 | DONOR-ID, version 1.0 | 2/27/1998 |
Dynal Biotech Ltd Croft Busines Park, UK |
BK050012 | Dynal RELI SSO HLA-DRB1 Typing Kit For use as a manual assay or with the AutoRELI 48 instrument |
5/18/2005 |
Dynal Biotech Ltd Bromborough, Wirral, UK |
BK030056 | Dynal Reli SSO HLA-A Typing Kit | 1/29/2004 |
Dynal Biotech Ltd Bromborough, Wirral, UK |
BK030057 | Dynal Reli SSO HLA-B Typing Kit | 1/29/2004 |
Dynal Biotech Ltd Bromborough, Wirral, UK |
BK030058 | Dynal Reli SSO HLA-Cw Typing Kit | 1/29/2004 |
Dynal Biotech Ltd Bromborough, Wirral, UK |
BK030059 | Dynal Reli SSO HLA-DQB1 Typing Kit | 1/29/2004 |
Dynal Biotech Ltd Bromborough, Wirral, UK |
BK030060 | Dynal Reli SSO HLA-DRB Typing System | 1/29/2004 |
Dynamic Healthcare Technologies, Inc Maitland, FL |
BK960041 | Transfusion Service Manager, Version 4.1.6 | 12/16/1997 |
Fenwal Inc. Three Corporate Drive Lake Zurich , IL 60047 |
BK080048 | AMICUS® Separator: Software 3.1 with EDI Export | 10/2/2008 |
Fenwal Inc. Three Corporate Drive Lake Zurich , IL 60047 |
BK080018 | Amicus Separator System | 8/26/2008 |
Fenwal Inc. Three Corporate Drive Lake Zurich , IL 60047 |
BK080033 | PLASMALINK | 8/22/2008 |
Fenwal Inc. Three Corporate Drive Lake Zurich , IL 60047 |
BK080024 | ALYX Component Collection System | 6/24/2008 |
Fifth Dimension Information Systems Edmonton, Alberta T5J 2Z2 CANADA |
BK050060 | E-Interview (eQue) 1.0.0 | 5/24/2006 |
Fifth Dimension Information Systems Edmonton, Alberta T5J 2Z2 CANADA |
BK040040 | LOGIC 2.0 | 10/6/2004 |
Fifth Dimension Information Systems Edmonton, Alberta T5J 2Z2 |
BK020058 | LOGIC 1.0 | 2/3/2003 |
Fresenius Hemocare Inc Lexington, MA 02420 |
BK040076 | Compodock | 12/17/2004 |
Fresenius Hemocare Inc Lexington, MA 02420 |
BK040005 | Fresenius Compoguard & Donationmaster NT | 3/26/2004 |
Fresenius Hemocare Inc Redmond, WA 98052 |
BK030022 | Fresenius Compomat G4 & Compomaster NT | 7/11/2003 |
Fujirebio Diagnostics, Inc Malvern, PA |
BK070030 | Olympus PK CMV-PA Test System and Controls for the Olympus PK7300 Automated Blood Bank Analyzer | 9/20/2007 | Fujirebio Diagnostics, Inc Malvern, PA |
BK060062 | Olympus PK TP Reagent System | 6/25/2007 |
Fujirebio Diagnostics, Inc Malvern, PA |
BK030007 | Olympus PK TP System | 2/21/2003 |
Gambro BCT, Inc Lakewood, CO 80215-4498 |
BK080010 | The Atreus Whole Blood Processing System | 6/27/2008 |
Gambro BCT, Inc Lakewood, CO 80215-4498 |
BK070066 | Vista Information System, Version 3.0 with Medical Review Module | 12/13/2007 |
Gambro BCT, Inc Lakewood, CO 80215-4498 |
BK040086 | COBE Spectra Apheresis System & Trima Automated Blood Component Collection System | 3/15/2005 |
Gambro BCT, Inc Lakewood, CO 80215-4498 |
BK040069 | Trima Automated Blood Component Collection System - Blood Component Sampling Accessary | 10/28/2004 |
Gambro BCT, Inc Lakewood, CO 80215-4498 |
BK010037 | Platelet collection sets for the COBE Spectra Apheresis System and the Trima Automated Blood Component Collection System | 9/24/2003 |
Gambro BCT, Inc Lakewood, CO 80215-4498 |
BK030021 | Vista Information System 2.1 | 5/1/2003 |
Gambro BCT, Inc Lakewood, CO 80215-4498 |
BK020041 | COBE Spectra Apheresis System/Blood component disposable collection sets for apheresis | 4/23/2003 |
Gambro BCT, Inc Lakewood, CO 80215-4498 |
BK010050 | Trima Automated Blood Collection System | 9/18/2002 |
Gambro BCT, Inc Lakewood, CO 80215-4498 |
BK010046 | Trima Automated Blood Collection System (Single Stage) | 9/18/2002 |
Gambro BCT, Inc Lakewood, CO 80215-4498 |
BK020015 | Vista Information System, Independent Solution | 7/15/2002 |
Gambro BCT, Inc Lakewood, CO 80215-4498 |
BK010006 | Trima Automated Blood Component Collection System | 2/27/2002 |
Gaymar Industries, Inc Washington, DC 20006-4706 |
BK060050 | Medi-Temp III, Model FW600 Blood/Fluid Warmer | 11/7/2006 |
GE Medical Information Technologies Barrington, IL |
BK050018 | Centricity Ultra Laboratory Transfusion Medicine (Ultra TM) 4.0 | 6/13/2005 |
Genetic Testing Institute Brookfield, WI |
BK960059 | PAKAUTO Platelet Antibody Screening Kit | 10/22/1998 |
Gen-Probe, Inc San Diego CA |
BK060021 | Procleix TIGRIS System for use with the Procleix WNV Assay | 2/20/2007 |
Greiner Bio-One North America, Inc. Monroe, NC 28110 |
BK050026 | Greiner Vacuette No Additive Tubes | 7/7/2005 |
Greiner Bio-One North America, Inc. Monroe, NC 28110 |
BK050028 | Greiner Vacuette Clot Activator Tube | 7/7/2005 |
Greiner Bio-One GmbH Westmont, IL 60659 |
BK030032 | Greiner Vacuette EDTA K2 Evacuated Blood Collection Tube | 7/18/2003 |
Greiner Bio-One GmbH Westmont, IL 60659 |
BK030001 | Greiner Vacuette EDTA K3 Tube | 2/26/2003 |
GTI, INC Waukesha, WI 53186 |
BK070045 | Donor Screen HLA Class I and Class II | 7/30/2008 |
GTI, INC Waukesha, WI 53186 |
BK060038 | MICROAMS | 7/28/2006 |
GTI, INC Waukesha, WI 53186 |
BK050054 | GranType | 3/2/2006 |
GTI, INC Waukesha, WI 53186 |
BK050040 | ThromboType (HPA 1-6, 15) and ThromboType 1 (HPA 1) | 1/20/2006 |
GTI, INC Waukesha, WI 53186 |
BK040034 | Lifecodes LifeScreen: A Luminex 100 Screening Assay for the Detection of IgG Antibodies to HLA Class I and Class II Molecules of Human Origin | 7/16/2004 |
GTI, INC Waukesha, WI 53186 |
BK040035 | Lifecodes ID Class I: A Luminex 100 screening assay for the qualitative detection of IgG panel reactive antibodies (PRA) to HLA Class I molecules Lifecodes ID Class II: A Luminex 100 screening assay for the qualitative detection of IgG panel reactive antibodies (PRA) to HLA Class II molecules |
7/16/2004 |
GTI, INC Waukesha, WI 53186 |
BK040019 | Antibody Monitoring System Class 1 and Class II (AMS1 and AMS1+2) | 7/6/2004 |
Haemonetics Corp Braintree, MA 02184 |
BK09004 | MCS+8150 System - Wireless | 2/20/2009 |
Haemonetics Corp Braintree, MA 02184 |
BK080038 | MCS+ 9000 System | 9/4/2008 |
Haemonetics Corp Braintree, MA 02184 |
BK080025 | Cymbal Automated Blood Collection System | 8/15/2008 |
Haemonetics Corp Braintree, MA 02184 |
BK080001 | PCS2 Plasma Collection System_Revision K software | 5/28/2008 |
Haemonetics Corp Braintree, MA 02184 |
BK060008 | Haemonetics ACP 215 Glycerolization/Deglycerolization System | 5/23/2006 |
Haemonetics Corp Braintree, MA 02184 |
BK050047 | MCS+9000, SDP revision E software, 994CF-CPP series disposable sets | 11/21/2005 |
Haemonetics Corp Braintree, MA 02184 |
BK050006 | ACP 215 Glycerolization/Deglycerolization System | 4/14/2005 |
Haemonetics Corp Braintree, MA 02184 |
BK040077 | Haemonetics Model 215 Automated Glycerolization/Deglycerolization System | 12/21/2004 |
Haemonetics Corp Braintree, MA 02184 |
BK040041 | Haemonetics MCS+8150 Apheresis System | 07/12/2004 |
Haemonetics Corp Braintree, MA 02184 |
BK040025 | PCS2 Plasma Collection System | 06/02/2004 |
Haemonetics Corp Braintree, MA 02184 |
BK040020 | Haemonetics LN994CF-BA Extended Storage Platelet and Plasma Apheresis Set with Leukocyte Reduction Filter, and 4 mL Sampling System | 03/29/2004 |
Haemonetics Corp Braintree, MA 02184 |
BK040001 | Haemonetics 4mL Sampling System | 02/27/2004 |
Haemonetics Corp Braintree, MA 02184 |
BK030062 | Haemonetics Model 215 Automated Glycerolyzation/deglycerolyzation System | 12/10/2003 |
Haemonetics Corp Braintree, MA 02184 |
BK030031 | Haemonetics Model 215 Automated Glycerolyzation/deglycerolyzation and Cell Washing System | 9/10/2003 |
Haemonetics Corp Braintree, MA 02184 |
BK010035 | MCS+ Mobile Collection System | 12/20/2002 |
Haemonetics Corp Braintree, MA 02184 |
BK020001 | Plasma Pooling Bottle II | 3/29/2002 |
Haemonetics Corp Braintree, MA 02184 |
BK000002 | Model 215 Automated Glycerlization and Deglycerolization System | 5/4/2001 |
Haemonetics Corp Braintree, MA 02184 |
BK000048 | Haemonetics LN832F | 4/9/2001 |
Haemonetics Corp Braintree, MA 02184 |
BK990033 | MCS+ LN8150 Red Cell Apheresis Instrument | 1/20/2000 |
Harvest Technologies Norwell, MA |
BK000037 | Harvest PRP Separation System | 2/5/2001 |
Healthcare-ID Buffalo Grove, IL |
BK060058 | Donor-ID 3.0 | 2/8/2007 |
Healthcare-ID Buffalo Grove, IL |
BK030049 | Donor-ID | 10/31/2003 |
Healthcare Management Systems, Inc Nashville TN 37203 |
BK050001 | Monitor Blood Administration Module Release 24.0 | 9/28/2005 |
Helmer Labs, Inc Noblesville, IN 46060 |
BK020029 | UltraCW (with Software version 3.13) | 10/04/2002 |
Hemasure, Inc Marlborough, MA |
BK980014 | HemaSure r|LS Pre-Storage Leukoreduction Filtration System for Red Blood Cells | 5/27/1999 |
Hemerus Medical, LLC |
BK080031 | HEMERUS LEUKOSEP ® HRC-600-C Leukocyte Reduction Filtration System for Red Blood Cells | 9/11/2008 |
HemoCue AB Sweden |
BK060048 | HemoCue Hb 301 System | 10/5/2006 |
HemoCue, Inc Potomac, MD |
BK030067 | HemoCue Donor Hb Checker System | 12/19/2003 |
HemoCue, Inc Potomac, MD |
BK030020 | Donor Hemoglobin Checker System | 4/17/2003 |
HemoCue, Inc Potomac, MD |
BK000043 | HemoCue Low Hemoglobin Analyzing System | 4/9/2001 |
Hemosystem, S.A. Richmond, VA |
BK040031 | Scansytem Bacterial Detection Device | 9/23/2004 |
Immucor, Inc Norcross, GA |
BK070054 | Galileo Automated Blood Bank System - Add the Reverse ABO Group Assay | 11/30/2007 |
Immucor, Inc Norcross, GA |
BK070040 | Galileo Automated Blood Bank System with assays to perform red blood cell phenotying | 9/28/2007 |
Immucor, Inc Norcross, GA |
BK070016 | Galileo Echo Automated Blood Bank System | 6/14/2007 |
Immucor, Inc Norcross, GA |
BK070015 | WB corQC | 6/14/2007 |
Immucor, Inc Norcross, GA |
BK070014 | DAT Positive Control Cell | 6/14/2007 |
Immucor, Inc Norcross, GA |
BK070013 | Monoclonal Control | 6/14/2007 |
Immucor, Inc Norcross, GA |
BK060009 | Galileo Automated Blood Bank System with Capture-S Syphilis Screening | 4/11/2006 |
Immucor, Inc Norcross, GA |
BK050050 | Galileo Automated Blood Bank System Capture-CMV | 11/14/2005 |
Immucor, Inc Norcross, GA |
BK040057 | Check cell (Weak) | 10/6/2004 |
Immucor, Inc Norcross, GA |
BK040024 | Capture-R Select Solid Phase System | 4/28/2004 |
Immucor, Inc Norcross, GA |
BK040013 | Galileo version 1.3.6 SP4/DMS version 1.26 | 4/23/2004 |
Immucor, Inc Norcross, GA |
BK000024 | ABS2000, Version 2 software (2.05.00A and 2.0500B) | 7/3/2001 |
Immucor, Inc Norcross, GA |
BK960019 | ABS2000 | 6/30/1998 |
Indico, Inc Edmonton, ALBERTA T6G 2E1 CANADA |
BK000008 | RadTag X-ray | 3/1/2000 |
Information Data Management, Inc Rosemont, IL 60018 |
BK070031 | IDM Symphony System 2.0 | 12/13/2007 | Information Data Management, Inc Rosemont, IL 60018 |
BK050014 | IDM Prelude System, Version 1.1 | 7/18/2005 |
Information Data Management, Inc Rosemont, IL 60018 |
BK020038 | Surround System, Version 3.2 | 10/8/2002 |
Information Data Management, Inc Rosemont, IL 60018 |
BK010028 | IDM Surround System 3.0 | 8/30/2001 |
Information Data Management, Inc Rosemont, IL 60018 |
BK000016 | Information Data Management Surround System 2.0 | 4/7/2000 |
Information Data Management, Inc Rosemont, IL 60018 |
BK950037 | Components & Distribution Information System | 8/26/1996 |
Information Data Management, Inc Rosemont, IL 60018 |
BK950045 | Donor Management Information Systems, vers.1.2 | 8/26/1996 |
Infra-Med Technologies, Inc Dallas, TX |
BK990018 | Hot Shot Fluid Warmer | 10/13/1999 |
IntelliDOT Corporation |
BK080006 | IntelliDOT Blood Product Administration | 6/13/2008 |
Invitrogen Corp Brown Deer WI |
BK070038 | AllSet Gold SSP | 9/26/2007 |
ITL Corporation, Ltd Fyshwick, Canberra, Australia |
BK980008 | Bloodpack Needle Protector (BNP) | 4/7/1998 |
Korchek Technologies, LLC Trumbull CT 06611 |
BK040053 | CareChek Patient Identification System, CareChek, Version 1.0 | 8/12/2005 |
Kowa Company, Ltd Rockville, MD 20852 |
BK030037 | LD-2000 Leukocyte Counter | 6/14/2004 |
Level 1 Technologies, Inc Rockland, MA 02370 |
BK020043 | Level 1 Fluid warming System | 6/16/2003 |
LifeSouth Community Blood Centers Inc Gainesville FL 32607 |
BK080017 | Integrated Blood Bank Information System (IBBIS) Registration Module v1.0 | 8/5/2008 |
Ljungber & Kogel Deerfield, IL |
BK990013 | Biomixer 330 & Biomixer 323 | 7/7/1999 |
MacoProductions S.A.S. Marietta , GA |
BK080060 | Leucolab LCG2 Leukoreduction System for AS-1, AS-3, and AS-5 Red Blood Cells | 1/15/2009 |
MacoProductions S.A.S. c/o Hoppe Regulatory Consultants Decatur, GA |
BK050041 | Leucolab LCG2 Leukoreduction System for Red Blood Cells | 10/12/2005 |
Maco Pharma c/o Hoppe Regulatory Consultants Decatur, GA |
BK030008 | Leucolab LCG2 Leukoreduction System for Red Blood Cells | 5/2/2003 |
MAK System SAS International Group FRANCE |
BK080002 | ePROGESA v5.0.1 | 5/13/2008 |
MAK-System France |
BK070062 | PROGESA 4.4h | 10/26/2007 |
MAK-System Paris France |
BK060035 | Patient Health Software 1.0 | 5/9/2007 |
MEDITECH Medical Information Technology, Inc. MEDITECH Circle Westwood MA 02090 |
BK080037 | MEDITECH Client Server Blood Bank module v5.6 | 10/30/2008 |
MEDITECH Medical Information Technology, Inc Westwood, MA |
BK980046 | Magic Client Server, Version 5.1 | 2/8/2000 |
Mediware Information Systems, Inc. Oak Brook, IL 60523 |
BK080049 | HCLL Transfusion, v3.0 | 10/22/2008 |
Mediware Information Systems, Inc Irving, TX 75038 |
BK060019 | LifeTrak / Donor 3.01 | 6/21/2006 |
Mediware Information Systems, Inc Irving, TX 75038 |
BK050011 | HCLL Donor 1.0 | 5/10/2005 |
Mediware Information Systems, Inc Irving, TX 75038 |
BK040047 | Instrument Interface Engine 1.0 | 7/16/2004 |
Mediware Information Systems, Inc Irving, TX 75038 |
BK030078 | HCLL 2.6 | 4/8/2004 |
Mediware Information Systems, Inc Dallas, TX 75235 |
BK010052 | LifeTrak Lab 2.03 | 6/17/2002 |
Mediware Information Systems, Inc Dallas, TX 75235 |
BK020046 | Hemocare LifeLine Version, 1.0 | 2/14/2003 |
Medsep Corporation |
BK090007 | Pall ® Acrodose TM PL System | 2/25/2009 |
Medsep Corp Pepper Pike, OH |
BK080003 | Pall® AcrodoseT PLus System, Platelet Pool and Store Set with in-Line Leukocyte Reduction Filter | 4/18/2008 |
Medsep Corp Covina, CA |
BK070004 | Pall eBDS | 6/26/2007 |
Medsep Corp Pepper Pike, OH |
BK050074 | Pall Acrodose PL System | 1/26/2006 |
Medsep Corp Covina, CA |
BK050034 | Pall Acrodose PL System, Platelet Pool and Store Set with eBDS | 9/28/2005 |
Medsep Corp Covina, CA |
BK020014 | Pall Bacterial Detection System (BDS) | 10/22/2002 |
Medsep Corp Covina, CA |
BK000032 | Modified Plasma Bag | 9/27/2000 |
Medsep Corp Covina, CA |
BK970040 | Medsep Plasma Bag (EVA Plastic) | 1/23/1998 |
Medserv, Inc Mount Kisco, NY 10549 |
BK010032 | Plasmapheresis Data System III 1.0 | 2/5/2002 |
Medtronic Sofamor Danek Memphis, TN 38132 |
BK040068 | Magellan Autologous Platelet Separator System | 11/9/2004 |
Medtronic Sofamor Danek Memphis, TN 38132 |
BK030040 | Magellan Autologous Platelet Separation System | 9/3/2003 |
Micro Typing Systems Inc. Pompano Beach, FL |
BK030023 | Ortho ProVue, Software Version: 2.10 | 05/30/2003 |
Microwave Medical System Acton, MA |
BK970045 | ThermoStat 900 Blood & IV Fluid Adm. Set | 03/6/1998 |
Microwave Medical System Acton, MA |
BK970044 | ThermoStat 900 | 1/23/1998 |
Mississippi Blood Services, Inc. Jackson, MS |
BK030065 | WebLab Online Laboratory System 2.0 | 12/22/2003 |
Misys Healthcare Systems Tucson, AZ 85711 |
BK040065 | Misys Laboratory Blood Bank and Blood Donor 6.0.1 | 10/22/2004 |
Mosum Technology India PVT LTD Great Neck NY |
BK060014 | PowerBANK Enterprise Edition version 1.0 | 3/30/2007 |
Neoteric Technology Ltd Vancouver British Columbia, Canada |
BK060041 | BloodTrack 4.1 | 10/17/2006 |
Neoteric Technology Ltd Vancouver British Columbia, Canada |
BK050032 | BloodTrack SafeTx Version 2.0 | 8/16/2005 |
Olympus America Inc Irving TX 75063-3104 |
BK050076 | TANGO Automated Blood Bank Analyzer System (HW Version 02/SW Version 3.0) | 12/16/2005 |
Olympus America Inc Irving, TX 75063-3104 |
BK040070 | Tango Automated Blood Bank Analyzer System | 3/22/2005 |
One Lambda, Inc Canoga Park, CA |
BK050070 | HLA Visual Software version 1.0 | 1/30/2006 |
One Lambda, Inc Canoga Park, CA |
BK050071 | HLATools Software, Version 1.0 | 1/30/2006 |
One Lambda, Inc Canoga Park, CA |
BK050008 | LABScreen Software | 7/8/2005 |
One Lambda, Inc Canoga Park, CA |
BK040049 | LabType Visual | 8/9/2004 |
One Lambda, Inc Canoga Park, CA |
BK030069 | LABScreen Products for use with LABScan 100 flow analyzer | 12/31/2003 |
One Lambda, Inc Canoga Park, CA |
BK980015 | FlowPRA | 7/23/1999 |
One Lambda, Inc Canoga Park, CA |
BK960062 | Micro SSP HLA Class II DNA typing Kit | 2/11/1998 |
OriGen BioMedical Austin, TX 78758 |
BK030036 | OriGen Cryostore Freezing Bags | 10/1/2003 |
Ortho-Clinical Diagnostics, Inc Rochester, NY |
BK070028 | VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls | 4/10/2008 |
Ortho-Clinical Diagnostics, Inc Raritan, NJ 08869-0606 |
BK990030 | Ortho Lab with Ortho Lab IC (Instrument Concentrator) | 4/3/2000 |
Pel-Freez Clinical Systems, LLC Brown Deer, WI 53223 |
BK000019 | UniTray SSP HLA Typing Kits | 1/29/2001 |
Pel-Freez Clinical Systems, LLC Brown Deer, WI 53223 |
BK030003 | UniMatch Plus | 2/25/2003 |
Perfusion Partners & Associates, Inc Fort Myers FL 33912 |
BK050055 | GenesisCS Component Concentrating System | 10/13/2006 |
Prescott Ideas LLC Tucson AZ 85710 |
BK060056 | Antibody Check 4.1 | 4/23/2007 |
Psyche Systems Corp Wellesley, MA 02481 |
BK010017 | System Blood Bank (SBB) Software 3.0 | 9/4/2001 |
R & D Systems, Inc Minneapolis, MN |
BK040063 | R & D Plasma Hemoglobin Hematology Control | 9/17/2004 |
R & D Systems, Inc Minneapolis, MN |
BK040012 | R&D Donor Checker Hematology Control | 3/5/2004 |
R & D Systems, Inc Minneapolis, MN |
BK000035 | R & D Leuko-Reduced RBC Control | 12/13/2000 |
R & D Systems, Inc Minneapolis, MN |
BK000036 | R & D Leuko-Reduced Plt Control | 12/13/2000 |
Rubin & Poor, Inc Maplewood, NJ 07040 |
BK030073 | Configurable Manual Batch Entry, Version 1.1A | 1/14/2004 |
Rubin & Poor, Inc Maplewood, NJ 07040 |
BK010025 | Chiron Procleix NAT Tracker 1.0E | 1/3/2002 |
Rubin & Poor, Inc Maplewood, NJ 07040 |
BK000030 | Configurable Laboratory Result Manager (CLRM) 1.0E | 11/23/2001 |
Rubin & Poor, Inc Maplewood, NJ 07040 |
BK080028 | Pool Results Manager Version 1.0C, Module for Roche NAT Testing Version 2.0A | 9/3/2008 |
Rubin & Poor, Inc Maplewood, NJ 07040 |
BK990008 | Rubin & Poor Configurable Manual Blot System 1.0C | 10/29/1999 |
Sanguin International Limited Hambden, CT |
BK980003 | Aurora / Fenestra 1.0 | 9/29/1999 |
Sarstedt, Inc Newton, NC |
BK070029 | S-Monovette ACD-A Blood Collection System | 9/21/2007 |
Sarstedt, Inc Newton, NC 28658 |
BK030006 | Transwaag Disk 01 | 2/27/2003 |
Sarstedt, Inc Newton, NC 28658 |
BK010045 | Sahara Blood & Plasma Warming Device | 12/21/2001 |
Sarstedt, Inc Newton, NC 28658 |
BK010042 | Transwaag KL | 12/12/2001 |
SCC Soft Computer Clearwater FL |
BK080020 | SoftBank II v23.2 | 8/12/2008 |
SCIMEDX Corp Denville, NJ |
BK960070 | Olympus PK-TP System Control Set | 6/19/1997 |
Separation Technology, Inc Altamonte Springs FL |
BK050056 | UltraChek Reference Controls - Product Code GLK UltraCrit Hematocrit Measurement Device - Product Code GKF |
12/12/2005 |
SG SCientific Gainesville, FL |
BK950057 | The Saber, (Segment Piercing Device) | 11/13/1995 |
Shared Medical Systems Malvern, PA |
BK960036 | SMS Blood Bank Transfusion System | 12/12/1997 |
Siemens Healthcare Diagnostics Inc. Berkeley , CA |
BK080073 | TRUGENE® HIV-1 Genotyping Kit and OpenGene® DNA Sequencing System | 1/15/2009 |
Sienna Partners Baldwin, MD |
BK040066 | Greiner VACUETTE No Additive Evacuated Blood Collection Tubes and Serum Clot Activator Blood Collection Tubes | 9/10/2004 |
Sienna Partners Baldwin, MD |
BK040018 | VACUETTE EDTA K2 tube; VACUETTE EDTA K3 tube | 7/28/2004 |
Smith & Nephew, Inc Memphis, TN |
BK060004 | Smith & Nephew Platelet Rich Concentrate (PRC) Preparation System | 5/2/2006 |
Soft Computer Consultants, Inc Palm Harbor, FL |
BK040048 | SoftBank II v23.1 with Database Management System Interface (DMSI) | 8/23/2004 |
Soft Computer Consultants, Inc Palm Harbor, FL |
BK040028 | SoftBank II version 23 with SoftScape | 5/7/2004 |
Soft Computer Consultants, Inc Palm Harbor, FL |
BK030018 | SoftBank II 23 | 4/17/2003 |
Soft Computer Consultants, Inc Palm Harbor, FL |
BK020006 | SoftDonor 4.1 | 2/27/2003 |
Soft Computer Consultants, Inc Palm Harbor, FL |
BK020021 | SoftBank II 22 | 9/11/2002 |
Stemco Biomedical, Inc Durham, NC |
BK040075 | Aldecount Progenitor Cell Enumeration Kit | 1/6/2005 |
Stemco Biomedical, Inc Durham, NC |
BK030064 | Aldecount Progenitor Cell Enumeration Kit | 12/31/2003 |
SysTec Computer Associates, Inc Mt. Sinai, NY |
BK060032 | LifeTec Elite 1.0 | 8/21/2006 |
SysTec Computer Associates, Inc Mt. Sinai, NY |
BK040026 | LifeTec Donor Verification and Collection System (DOVAC) 1.00 | 10/21/2004 |
Talisman Ltd Vienna, VA |
BK070020 | Quality Donor System v2.1 | 7/16/2007 |
Talisman Ltd Vienna, VA |
BK060031 | Talisman Phlebotomy System, Release 1.0 | 7/27/2006 |
Talisman Ltd Vienna, VA |
BK040062 | Quality Donor System 2004 2.0 | 10/18/2004 |
Tepnel Lifecodes Corporation Stamford CT 06902 |
BK050003 | LIFECODES HLA-A, HLA-B, HLA-C, HLA-DQB and HLA-DRB Typing Kits for use with Luminex 100 | 7/18/2005 |
Terumo Medical Corp Elkton, MD |
BK040082 | TSCD-II Terumo Sterile Tubing Welder | 4/5/2005 |
Terumo Medical Corp Elkton, MD |
BK020033 | Imugard III-PL Leukocyte reduction filter | 5/22/2003 |
Terumo Medical Corp Elkton, MD |
BK970008 | Terumo Sterile Tubing Welder SC-201A (TSCD) | 5/28/1998 |
Terumo Medical Corp Elkton, MD |
BK970011 | Terumo Phlebotomy Needle Cap Holder | 6/19/1997 |
Texas BioGene, Inc Richardson TX |
BK060060 | Morgan HLA SSP ABDR Typing Kit | 3/22/2007 |
Thermogenesis Rancho Cordova, CA |
BK960072 | CryoSeal System | 2/12/1999 | Thermogenesis Rancho Cordova, CA |
BK070006 | AXP AutoXpress Platform | 10/5/2007 |
The Surgical Company International Netherlands |
BK070055 | Fluido Accessories: Fluido Air Guard, Fluido Compressor, Fluido IV-Pole and Fluido Pressure Chamber | 1/15/2008 |
The Surgical Company International The Netherlands |
BK050058 | Fluido Blood and Fluid Warmer System | 5/5/2006 |
Utah Medical Products, Inc Midvale, UT |
BK970026 | Umbilicup | 1/28/1998 |
VEEGEE Scientific Kirkland, WA 98034 |
BK010043 | Atago SP-D2 Refractometer | 1/2/2002 |
Verax Biomedical Inc Worcester, MA |
BK070044 | Platelet PGD Test System | 9/17/2007 |
Visible Genetics, Inc Toronto, Ontario |
BK000038 | TRUEGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System | 9/26/2001 |
Wyndgate Technologies El Dorado Hills CA |
BK070064 | ElDorado Donor 1.0.0 | 2/13/2008 |
Wyndgate Technologies El Dorado Hills CA |
BK070010 | ElDorado Donor Doc 1.0.0 | 5/23/2007 |
Wyndgate Technologies Rancho Cordova, CA |
BK980023 | SafeTrace TX, version 1.0 | 1/29/1999 |
ZLB Behring AG Bern, Switzerland |
BK050078 | System for Plasma Identification (SPI) 2.0.0 | 12/22/2005 |
ZLB Bioplasma AG Bern, Switzerland |
BK020020 | System for Plasma Identification (SPI) 1.0 | 10/30/2002 |