1996 Biological Device Application Approvals
This list reflects information regarding the applications as of the approval date; it is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval.
| Tradename | Description and Indication for Device | Applicant | Number | Approval Date |
|---|---|---|---|---|
| Blood Storage Refrigerator REB-2304 | Blood Storage Refrigerator | Revco/Lindberg Asheville, NC 28804 |
BK950054 | 1/11/1996 |
| Katzen Thrombolysis Guidewire | Infusion Catheter | Boston Scientific Corp Place Natick, MA 01760-1537 |
BK940025 | 1/24/1996 |
| COBE Spectra LRS Leuko-reduction System (Ver. 5) | Automated Blood Cell Separator | COBE BCT, Inc Lakewood, CO 80215 |
BK950056 | 1/31/1996 |
| Blood Storage Refrigerator HLT-30V-4BB |
Blood Storage Refrigerator | Revco/Lindberg Asheville, NC 28804 |
BK950066 | 1/31/1996 |
| Cryocyte Freezing Container | Blood Component Freezing Container | Baxter Healthcare Corp Irvine, CA 92718 |
BK950049 | 2/14/1996 |
| Thermal Wave | Blood and Plasma Thermer | Thermal Transfer Technology Placerville, CA 95667 |
BK950067 | 2/15/1996 |
| Double Product Collection (SDP-3) | Apheresis Hardware & Disposable Collection Sets | Haemonetics Corp Braintree, MA 02184 |
BK950034 | 2/15/1996 |
| COBE Spectra Extended Life with Integrated Leukoreduction Filter | Automated Blood Cell Separator Platelet Set | COBE BCT Lakewood, CO 80215 |
BK950030 | 2/15/1996 |
| Cyto-Therm-S | Plasma Thawer | Photo-Therm Trenton, NJ 08610 |
BK960012 | 4/15/1996 |
| MTS Centrifuge Model #9310 | Centrifuge | Micro Typing Systems, Inc Pompano Beach, FL 33069 |
BK960013 | 4/15/1996 |
| Haemonetics PCS2 | Apheresis Hardware and Disposable Collection Set | Haemonetics Corp Braintree, MA 02184 |
BK950033 | 4/16/1996 |
| Confide | HIV-Blood Testing Service | Direct Access Diagnostics Bridgewater, NJ 08807 |
BP900003 | 5/14/1996 |
| [NONE] | Cell Wash Set | Baxter Healthcare Irvine, CA 91203 |
BK960010 | 5/22/1996 |
| OraSure HIV-1 Western Blot Kit | HIV Sample Collection Kit | Epitope Inc Beaverton, OR 97005 |
BP950004 | 6/3/1996 |
| Roche Amplicor HIV-1 Monitor Test | HIV Monitor Test | Roche Molecular Systems, Inc Somerville, NJ |
BK950005 | 6/3/1996 |
| Olympus PK CMV System and System Controls | Anti-CMV Kit | Hemagen Diagnostics, Inc Waltham, MA 02154 |
BK940035 | 7/15/1996 |
| Fresenius AS104 Cell Separator | Automated Blood Cell Separator | Fresenius USA, Inc Walnut Creek, CA 94598 |
BK980007 | 7/22/1996 |
| Red Blood Cell & Apheresis Set #823 | Apheresis Collection Set | Haemonetics Corp Braintree, MA 02184 |
BK950063 | 7/22/1996 |
| Home Access HIV-1 Test System | HIV Sample Collection Kit | Home Access Health Corp Hoffman Estates, IL 60195-5200 |
BP950002 | 7/22/1996 |
| Jewett Models BPL13, BPL21,BPL25 | Blood Storage Refrigerators and Freezers | Jewett Refrigerator Co, Inc Buffalo, NY 14213-1098 |
BK960054 | 8/8/1996 |
| ACT Bouyant Density Solution | Silanated Collodial Silica Supplemented with Polyvinynolidone | Activated Cell Therapy, Inc 291 Bernardo Avenue Mountain View, CA 94043 |
BK960002 | 8/12/1996 |
| Components and Distribution Information System | CDIS, Ver. 1.1 Blood bank software used to receive and store data in the testing, manufacturing, and distribution of blood and blood products | Information Data Management, Inc Rosemont, IL 60018 |
BK950037 | 8/26/1996 |
| Donor Mgmt. Information Systems | DMIS, Ver. 1.2 Blood bank software used to receive and store data in the testing, manufacturing, and distribution of blood and blood products | Information Data Management, Inc Rosemont, IL 60018 |
BK950045 | 8/26/1996 |
| Eagle Series Blood Storage Refrigerator # ST30RGBB & ST50 | Blood storage refrigerator | Frigidaire Commercial Products Company 707 Robins St Conway, AR 72032 |
BK960066 | 8/30/1996 |
| CharterMed Transfer Bags | Empty Blood Collection and Processing Containers | CharterMed, Inc Lakewood, NJ 08701 |
BK960043 | 9/11/1996 |
| OPUS CMV | Test for antibody to CMV | Behring Diagnostics 175 University Ave Westwood, MA 02090 |
BK960001 | 10/9/1996 |
| Double Unit RBC Apheresis Set for the MCS+ List No. 833 | Aheresis collection device to collect 2 units of red blood | Haemonetics Corp 400 Wood Road Braintree, MA 02184 |
BK960006 | 10/15/1996 |
| Coombs Control Cells (EigG) Strong | Quality control kit for blood banking reagents to verify negative Coombs test results | Gamma Biologicals, Inc 3700 Mangum Road Houston, TX 77092 |
BK960055 | 10/23/1996 |
| Coombs Control Cells (EigG) Weak | Quality control kit for blood banking reagents to verify negative Coombs test results | Gamma Biologicals, Inc 3700 Mangum Road Houston, TX 77092 |
BK960056 | 10/23/1996 |
| Anti-B27 FITC/CD3PE Conjugated Monab | Leukocyte typing tray to test leukocytes for B27 | One Lambda, Inc 21001 Kittridge St Canoga Park, CA 91303 |
BK960053 | 10/30/1996 |
| Radtag | Blood banking devices used to indicate blood was irradiated at appropriated range | Indico, Inc 222 Campus Towers 8625 112th Street Edmonton, ALBERTA T6G2E1 |
BK960068 | 10/30/1996 |
| Models BBR17, BBR25m BBR36 and BBR55 | Blood storage refrigerator and freezer to store blood and blood products | Jewett Refrigerator Co, Inc 2-18 Letchworth Street Buffalo, NY 14213-1098 |
BK960073 | 10/30/1996 |
| Y-Type Rejuvenation Set - PN7212 | Plastic Tubing for Fluid Transfer | Cytosol Labs., Inc 55 Messina Drive Braintree, MA 02184 |
BK950060 | 11/25/1996 |
| CEPRATE SC Stem Cell Concentration System | Device to process autologous bone marrow to obtain CD34+ cell enriched population | CellPro, Inc 22215 26th Ave, S.E. Bothell, WA 998021 |
BP940001 | 12/6/1996 |
| Amicus Separator Automated Centrifugal Blood Cell Separator | Blood Cell Separator | Baxter HealthCare Corp 1 Baxter Parkway Deerfield, IL 60015 |
BK960005 | 12/19/1996 |