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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
Applicant
Becton, Dickinson and Company
10865 ROAD TO THE CURE,
SUITE 200
SAN DIEGO,  CA  92121
Applicant Contact Gregory P Payne
Correspondent
Becton, Dickinson and Company
10865 ROAD TO THE CURE,
SUITE 200
SAN DIEGO,  CA  92121
Correspondent Contact Gregory P Payne
Regulation Number866.3740
Classification Product Code
GTY  
Date Received09/05/2012
Decision Date 02/06/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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