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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name trichomonas vaginalis nucleic acid amplification test system
510(k) Number K161619
Device Name Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems
Applicant
Cepheid
904 Carribean Drive
sunnyvale,  CA  94089 -1189
Applicant Contact scott a. campbell
Correspondent
Cepheid
904 Carribean Drive
sunnyvale,  CA  94089 -1189
Correspondent Contact scott a. campbell
Regulation Number866.3860
Classification Product Code
OUY  
Subsequent Product Codes
JSM   OOI  
Date Received06/13/2016
Decision Date 08/29/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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