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