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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification
510(k) Number K101564
Device Name CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL
Original Applicant
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 clifton rd., n.e.
mailstop c-12
atlanta,  GA  30333
Original Contact hye-joo kim
Regulation Number866.3332
Classification Product Code
OQW  
Date Received06/04/2010
Decision Date 06/22/2010
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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