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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name antigens, all groups, streptococcus spp.
510(k) Number K122718
Device Name BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP
Original Applicant
BECTON, DICKINSON AND COMPANY
10865 road to the cure,
suite 200
san diego,  CA  92121
Original Contact gregory p payne
Regulation Number866.3740
Classification Product Code
GTY  
Date Received09/05/2012
Decision Date 02/06/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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