|
|
|
|
|
|
|
|
|
|
|
|
|
| Dockets Entered On September
24, 2004
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1981N-0033P
|
| Antigingivitis & Antiplaque-Related
Claims
|
|
| 2000D-1392
|
| Guidance for Industry on Botanical
Drug Products
|
|
| 2000N-0504
|
| Egg Safety Action Plan
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity
for Hearing
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives
from Rx to OTC
|
|
| 2003D-0309
|
| Guidance for Industry and FDA
staff: Medical Device User Fee and Modernization Act of 2002, Validation
Data in Premarket Notification Submissions [ 510(k)s] for Reprocessed
Single-Use Medical Devices:
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety
System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture
and Distribution of Animal Feeds
|
|
| 2004D-0028
|
| Draft Consumer Advisory regarding
Advice for Subgroups of a Population regarding Mercury in Fish and
Shellfish
|
|
| 2004M-0341
|
| P030024 - Vitros Immunodiagnostic
Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products
Anti-HBc Calibrator
|
|
|
| 2004M-0356
|
| P030026 - Vitros Immunodiagnostic
Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products
Anti-HBc IgM Calibrator
|
|
|
| 2004M-0430
|
| P010012/S026 - CONTAK CD (Model
1823), CONTAK CD 2 (Models H115 and H119), RENEWAL (Model H135), RENEWAL
3 (Models H170, H175, H177, and H179)
|
|
|
| 2004M-0433
|
| P030044 - DakoCytomation EGFR
pharmDx
|
|
| 2004N-0033
|
| Factor VIII Inhibitors
|
|
|
| 1981N-0033P
|
| Antigingivitis & Antiplaque-Related
Claims
|
|
| EC
4
|
| Colgate-Palmolive Company
|
| Vol #:
|
| 86
|
|
|
| 1997D-0530
|
| Use of IEC 60601 Standards;
Medical Electrical;
|
|
|
| EC 4
|
| Mr. Edward Keller
|
| Vol #:
|
| 1
|
|
|
| 2000D-1392
|
| Guidance for Industry on
Botanical Drug Products
|
|
|
| EC 3
|
| Ms. Sharla Cooper
|
| Vol #:
|
| 1
|
|
|
| EC 4
|
| unii
|
| Vol #:
|
| 1
|
|
|
| EC
5
|
| Shanghai Comman Pharmaceutical
Co., Ltd
|
| Vol #:
|
| 1
|
|
|
| 2000N-0504
|
| Egg Safety Action Plan
|
|
|
| BKG 1
|
| Background Material Refs 1 -
140
|
| Vol #:
|
| 11
|
|
|
| NPR
1
|
| FDA
|
| Vol #:
|
| 11
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry:
Opportunity for Hearing
|
|
| EXB 541
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 434
|
|
|
| EXB 542
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 434
|
|
|
| EXB 543
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 434
|
|
|
| EXB 544
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 434
|
|
|
| EXB 545
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 434
|
|
|
| EXB 546
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 434
|
|
|
| EXB 547
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 435
|
|
|
| EXB 548
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 435
|
|
|
| EXB 549
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 435
|
|
|
| EXB 550
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 435
|
|
|
| EXB 551
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 435
|
|
|
| EXB 552
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 435
|
|
|
| 2001P-0075
|
| Switch Status of Emergency
Contraceptives from Rx to OTC
|
|
|
| EC 812
|
| Dr. Eric Siegal
|
| Vol #:
|
| 163
|
|
| | | | | | | | |
|
|
| EC 813
|
| Mr. David Kothman
|
| Vol #:
|
| 163
|
|
|
| EC 814
|
| Catholic Priest
|
| Vol #:
|
| 163
|
|
|
| EC
815
|
| Planned Parenthood of Central North Carolina
|
| Vol #:
|
| 163
|
|
|
| EC 816
|
| Dr. Arnold Jago
|
| Vol #:
|
| 163
|
|
|
| EC
817
|
| Crisis Pregnancy Services
|
| Vol #:
|
| 163
|
|
|
| EC 818
|
| Ms. Carolyn Mott
|
| Vol #:
|
| 163
|
|
|
| 2003D-0309
|
| Guidance for
Industry and FDA staff: Medical Device User Fee and Modernization
Act of 2002, Validation Data in Premarket Notification Submissions
[510(k)s] for Reprocessed Single-Use Medical Devices:
|
|
|
|
|
|
| EC 1
|
| Mrs. Michelle Crook
|
| Vol #:
|
| 1
|
|
|
| EC 2
|
| Exportadora Quisqueya S.A
|
| Vol #:
|
| 1
|
|
|
| EC 4
|
| Tiia Hyde family
|
| Vol #:
|
| 1
|
|
|
| 2003D-0538
|
| Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification Submissions 510(k): Effect on FDA Review Clock and Performance Assessment
|
|
|
| EC 2
|
| Smith
|
| Vol #:
|
| 1
|
|
|
| EC 3
|
| Smith
|
| Vol #:
|
| 1
|
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
|
|
| EC
12
|
| Wood Co. Industrial Commission
|
| Vol #:
|
| 4
|
|
|
| EC
13
|
| Arise Direct Marketing, Inc.
|
| Vol #:
|
| 4
|
|
|
| 2004D-0028
|
| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
|
|
|
| EC
8
Attachment
|
| Pacific Health Education Center
|
| Vol #:
|
| 1
|
|
|
| 2004M-0341
|
| P030024 - Vitros Immunodiagnostic Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc Calibrator
|
|
|
| CR
1
|
| Ortho-Clinical Diagnostics, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004M-0356
|
| P030026 - Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator
|
|
|
| CR
1
|
| Ortho-Clinical Diagnostics, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004M-0430
|
| P010012/S026 - CONTAK CD (Model 1823), CONTAK CD 2 (Models H115 and H119), RENEWAL (Model H135), RENEWAL 3 (Models H170, H175, H177, and H179)
|
|
|
| AAV
1
|
| Guidant Corporation
|
| Vol #:
|
| 1
|
|
|
| 2004M-0433
|
| P030044 - DakoCytomation EGFR pharmDx
|
|
|
| AAV
1
|
| DakoCytomation California, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004N-0033
|
| Factor VIII Inhibitors
|
|
|
| EC
2
|
| Abbott Labs - Retired/disability
|
| Vol #:
|
| 4
|
|