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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 K070462
Device Name XPERT MRSA
Applicant
CEPHEID
904 caribbean drive
sunnyvale,  CA  94089 1189
Contact russel k enns
Regulation Number866.1640
Classification Product Code
NQX  
Date Received02/16/2007
Decision Date 04/17/2007
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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