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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 K162331
Device Name Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
Applicant
CEPHEID
904 CARIBBEAN DRIVE
Sunnyvale,  CA  94089
Applicant Contact SCOTT A. CAMPBELL
Correspondent
CEPHEID
904 CARIBBEAN DRIVE
Sunnyvale,  CA  94089
Correspondent Contact JIM KELLY
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
JSM   OOI  
Date Received08/19/2016
Decision Date 02/09/2017
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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