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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
904 Carribean Drive
Sunnyvale,  CA  94089 -1189
Applicant Contact Scott A. Campbell
904 Carribean Drive
Sunnyvale,  CA  94089 -1189
Correspondent Contact Scott A. Campbell
Regulation Number866.3860
Classification Product Code
Subsequent Product Codes
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