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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gastrointestinal pathogen panel multiplex nucleic acid-based assay system
510(k) Number K142501
Device Name Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
Applicant
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE,  CA  94089 -1189
Applicant Contact KERRY J. FLOM
Correspondent
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE,  CA  94089 -1189
Correspondent Contact SCOTT A. CAMPBELL
Regulation Number866.3990
Classification Product Code
PCH  
Date Received09/05/2014
Decision Date 11/26/2014
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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