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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 K101879
Model GXMRSA/SA-BC-10
Device Name XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10
Original Applicant
CEPHEID
904 caribbean drive
sunnyvale,  CA  94089 1189
Original Contact russel k enns, ph.d.
Regulation Number866.1640
Classification Product Code
NQX  
Date Received07/06/2010
Decision Date 07/28/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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