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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, genotypic detection, resistant markers, enterococcus species
510(k) Number K092953
Device Name XPERT VANA ASSAY
Original Applicant
CEPHEID
904 caribbean drive
sunnyvale,  CA  94089 1189
Original Contact russel k enns
Regulation Number866.1640
Classification Product Code
NIJ  
Subsequent Product Code
OOI  
Date Received09/24/2009
Decision Date 12/17/2009
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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