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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 Dr.
Sunnyvale,  CA  94089 -1189
Applicant Contact RUSSEL K ENNS
Correspondent
Cepheid
904 Caribbean Dr.
Sunnyvale,  CA  94089 -1189
Correspondent Contact RUSSEL K ENNS
Regulation Number866.1640
Classification Product Code
NQX  
Date Received07/30/2008
Decision Date 09/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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