Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail Us]

DOCKETS ENTERED on December 5, 2001

TABLE OF CONTENTS

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[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]

 
94S-0120 510K Substantially Equivalent List *
97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection) *
01N-0370 Progress on implementing for the common technical document *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *

77N-0085 Saccharin and Its Salts

CA 22049 Number Not Used Vol#: 445

CA 22319 Mr. & Mrs. J. R. Sholund Vol#: 448

CA 22357 Jack D. Sidler Vol#: 449

CA 22439 C. Tuttle Vol#: 450

94S-0120 510K Substantially Equivalent List

LST 107 List of October 2001 Vol#: 25

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 554 HFS-810 to Earthwise Nutritionals Inc Vol#: 16

LET 555 HFS-810 to Jamieson Laboratories Vol#: 16

LET 556 HFS-810 to Pharmavite Corporation Vol#: 16

LET 557 HFS-810 to Rexall-Sundown Inc Vol#: 16

LET 558 HFS-810 to OvImmune Inc Vol#: 16

LET 559 HFS-810 to Enzymatic Therapy Inc Vol#: 16

00D-1538 Electronic Records; Electronic Signatures, Validation

LST 6 General References for Guidance Document Vol#: 5

00D-1539 Electronic Records & Signatures, Retention of Electronic Rec

LST 6 General References for Guidance Document Vol#: 5

00D-1540 Electronic Signatures, Electronic Copies of Electronic Recor

LST 6 General References for Guidance Document Vol#: 5

00D-1541 Electronic Signatures: Audit Trails

C 1 PhRMA Vol#: 5

LST 6 General References for Guidance Document Vol#: 5

RPT 8 Datum EBA (Datum Trusted Time Stamp Serv Vol#: 5

00D-1542 Electronic Signatures: Time Stamps

LST 6 General References for Guidance Document Vol#: 5

00D-1543 Electronic Signatures: Glossary of Terms

LST 6 General References for Guidance Document Vol#: 5

01M-0507 P990012; Elecsys HBsAg Immunassay, Elecsys HBsAg Confirmator

CR 1 HFZ-402 Vol#: 1

01M-0534 P010032; Genesis Neurostimulation (IPG) System

AAV 1 Advanced Neuromodulation System, Inc. Vol#: 1

01M-0535 P930027/S004; Immulite PSA, Third Generation PSA, 2000, etc

AAV 1 Diagnostic Products Corporation Vol#: 1

01M-0536 P010021; Vitros Immunodiagnostic Products Anti-HCV etc.

AAV 1 Ortho-Clinical Diagnostics, Inc. Vol#: 1

01M-0537 P010007; Immulite AFP and Immulit 2000 AFP

AAV 1 Diagnostic Products Corporation Vol#: 1

01N-0370 Progress on implementing for the common technical document

C 1 AstraZeneca Pharmaceuticals LP Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 567 Jennifer Washburn Vol#: 82

C 568 Rosemary Galiani Vol#: 82

C 569 Julie Merritt Daisy Vol#: 82

C 570 Betty Erhart Vol#: 82

C 571 J. Vignone Vol#: 82

C 572 illegible Vol#: 82

C 573 Miriam MacGillis Vol#: 82

C 574 Mark Helms Vol#: 82

C 575 James T. Martin Vol#: 82

C 576 David Zimmerman Vol#: 82

C 577 Anna Watson Vol#: 82

C 578 Peter Richards Vol#: 82

C 579 Natalie Winblade Vol#: 82

C 580 Vivian Casper Vol#: 82

C 581 Marilyn Vranka Vol#: 82

C 582 Mrs. Kathleen E. Moss Vol#: 82

C 583 Jeff & Mary Clement-Hill Vol#: 82

C 584 Gordy Ohliger Vol#: 82

C 585 Noel Forrest Vol#: 82