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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 K130268
Device Name BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY
Applicant
BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152 -0999
Applicant Contact EMILY HOWARD
Correspondent
BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152 -0999
Correspondent Contact EMILY HOWARD
Regulation Number866.3860
Classification Product Code
OUY  
Date Received02/04/2013
Decision Date 08/23/2013
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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