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2003P-0564: 513(f) Reclassification Petition for In Vitro Diagnostics for Anti-Hepatitis A Virus IgM and Total Antibodies
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| Document #
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| Received Date
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| Filed Date
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| Submitter Code
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| Submitter
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| FR Date
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| FR Page
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| Comment Date
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| Files
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| Remarks
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| CCP1
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| 12/16/2003
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| 10/01/2003
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| Private
Industry
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| Beckman Coulter,
Inc.
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| pdf
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| Signature:
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| Barbara Chiponis
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| ACK1
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| 12/16/2003
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| 12/16/2003
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| Federal
Government
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| HFA-305 to Beckman
Coulter, Inc.
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| htm
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| Signature:
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| Lyle D. Jaffe
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| BKG1
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| 09/29/2004
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| 09/29/2004
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| Federal
Government
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| References 1 -
10
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No document
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| Signature:
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| References 1 - 10
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| NPR1
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| 09/29/2004
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| FDA
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| FDA
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| 03/15/2004
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| 12158-12158
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| 12/29/2004
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| pdf
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| Signature:
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| SHUREN, JEFFREY
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| EC1
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| 12/24/2004
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| 12/23/2004
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| Association
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| AdvaMed
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| htm
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| Signature:
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| Jones, Carolyn
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| C1
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| 12/29/2004
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| 12/28/2004
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| Drug Industry
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| Abbott
Laboratories
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| pdf
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| Signature:
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| April Veoukas, J.D.
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| NFR1
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| 02/08/2006
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| FDA
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| FDA
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| 02/09/2006
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| 6677-6679
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| pdf
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| Eff: 3/13/2006
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| Signature:
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| KAHAN, S. LINDA
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| NCR1
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| 02/28/2006
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| FDA
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| FDA
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| 03/01/2006
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| 10433-10433
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| pdf
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| Eff: March 13,
2006
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| Signature:
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| KAHAN, S. LINDA
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Top | Up
Page last updated:
August 24, 2007
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