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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nucleic acid-based, mycobacterium tuberculosis complex, resistance marker, direct specimen
510(k) Number K131706
Device Name XPERT MTB/RIF ASSAY
Original Applicant
CEPHEID
904 caribbean drive
sunnyvale,  CA  94089
Original Contact kerry j flom
Regulation Number866.3373
Classification Product Code
PEU  
Date Received06/11/2013
Decision Date 07/25/2013
Decision de novo petitions granted (AN)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
FOI Item Approval Letter
FDA Review Decision Summary
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No
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