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2007P-0210:
Reclassification Petition for Human Papillomavirus (HPV) DNA Nested
Polymerase Chain Reaction (PCR) Detection under Section 513(f),
21 CFR 860 Subpart C
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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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| 05/22/2007
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| 05/22/2007
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| Private Industry
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| HiFi DNA Tech, LLC
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| Table
of Contents
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| Signature:
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| Sin Hang Lee, M.D.
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| ACK1
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| 05/22/2007
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| 05/22/2007
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| Federal Government
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| FDA/DDM to HiFi DNA
Tech, LLC
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| pdf
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| Signature:
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| Lyle D. Jaffe
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| CCP2
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| 08/14/2007
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| 08/14/2007
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| Private Industry
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| HiFi DNA Tech, LLC
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| pdf,
Copyrighted Material
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| Signature:
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| Sin Hang
Lee
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| LET1
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| 10/22/2007
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| 10/22/2007
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| Private Industry
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| HiFi DNA Tech, LLC
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| pdf,
Copyrighted Material
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| Signature:
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| Sin Hang Lee
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Top
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Page last updated:
October 26, 2007
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