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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 K120911
Device Name XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)
Original Applicant
CEPHEID
904 caribbean drive
sunnyvale,  CA  94089 1189
Original Contact kerry j flom
Regulation Number866.3332
Classification Product Code
OQW  
Subsequent Product Codes
OCC   OOI  
Date Received03/26/2012
Decision Date 05/18/2012
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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