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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 K100822
Device Name XPERT MRSA/SA NASAL ASSAY
Applicant
Cepheid
904 Caribbean Dr.
Sunnyvale,  CA  94089
Applicant Contact RUSSEL K ENNS
Correspondent
Cepheid
904 Caribbean Dr.
Sunnyvale,  CA  94089
Correspondent Contact RUSSEL K ENNS
Regulation Number866.1640
Classification Product Code
NQX  
Subsequent Product Code
OOI  
Date Received03/23/2010
Decision Date 06/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
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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