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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

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
CCP1 05/22/2007 05/22/2007 Private Industry HiFi DNA Tech, LLC       Table of Contents  
Signature: Sin Hang Lee, M.D.
ACK1 05/22/2007 05/22/2007 Federal Government FDA/DDM to HiFi DNA Tech, LLC       pdf  
Signature: Lyle D. Jaffe
CCP2 08/14/2007 08/14/2007 Private Industry HiFi DNA Tech, LLC       pdf,
Copyrighted Material
 
Signature: Sin Hang Lee
LET1 10/22/2007 10/22/2007 Private Industry HiFi DNA Tech, LLC       pdf,
Copyrighted Material
 
Signature: Sin Hang Lee

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Page last updated: October 26, 2007