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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 K151589
Device Name BD MAX CT/GC/TV, BD MAX INSTRUMENT
Applicant
BECTON, DICKINSON, AND COMPANY
7 LOVETON CIR. MC:694
SPARKS,  MD  21152
Applicant Contact KATIE COYLE
Correspondent
BECTON, DICKINSON, AND COMPANY
7 LOVETON CIR. MC:694
SPARKS,  MD  21152
Correspondent Contact KATIE Edwards
Regulation Number866.3860
Classification Product Code
OUY  
Subsequent Product Codes
LSL   MKZ  
Date Received06/12/2015
Decision Date 09/06/2016
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
Recalls CDRH Recalls
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