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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
Device Name XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10
Applicant
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE,  CA  94089 -1189
Applicant Contact RUSSEL K ENNS, PH.D.
Correspondent
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE,  CA  94089 -1189
Correspondent 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 (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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