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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 amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen
510(K) Number K082140
Device Name XPERT MRSA/SA BLOOD CULTURE ASSAY
Applicant
CEPHEID
904 caribbean drive
sunnyvale,  CA  94089 1189
Contact russel k enns
Regulation Number866.1640
Classification Product Code
NQX  
Date Received07/30/2008
Decision Date 09/29/2008
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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