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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Virus Panel Nucleic Acid Assay System
510(k) Number K142045
Device Name XPERT FLU/RSV XC ASSAY
Applicant
Cepheid
904 Caribbean Dr.
Sunnyvale,  CA  94089
Applicant Contact SCOTT A CAMPBELL,PH.D.,MBA
Correspondent
Cepheid
904 Caribbean Dr.
Sunnyvale,  CA  94089
Correspondent Contact SCOTT A CAMPBELL,PH.D.,MBA
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Code
OOI  
Date Received07/28/2014
Decision Date 11/22/2014
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
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