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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nucleic acid amplification assay system, group b streptococcus, direct specimen test
510(k) Number K060540
Device Name XPERT, GENEXPERT DX SYSTEM
Original Applicant
CEPHEID
904 caribbean drive
sunnyvale,  CA  94089 1189
Original Contact russel k enns
Regulation Number866.3740
Classification Product Code
NJR  
Date Received03/02/2006
Decision Date 07/25/2006
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
Recalls CDRH Recalls
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