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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 K151565
Device Name Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit
Applicant
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE,  CA  94089
Applicant Contact KERRY J. FLOM
Correspondent
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE,  CA  94089
Correspondent Contact SCOTT A. CAMPBELL
Regulation Number866.3860
Classification Product Code
OUY  
Subsequent Product Code
OOI  
Date Received06/10/2015
Decision Date 10/16/2015
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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