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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 DRIVE
SUNNYVALE,  CA  94089 -1189
Applicant Contact SCOTT A CAMPBELL,PH.D.,MBA
Correspondent
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE,  CA  94089 -1189
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
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