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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name c. difficile nucleic acid amplification test assay
510(k) Number K110203
Model GXCDIFF/EPI-10
Device Name XPERT C. DIFFICLE/EPI ASSAY
Original Applicant
CEPHEID
904 caribbean drive
sunnyvale,  CA  94089 1189
Original Contact russel k enns
Regulation Number866.2660
Classification Product Code
OMN  
Date Received01/24/2011
Decision Date 04/07/2011
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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