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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name antigen, cf (including cf controls), respiratory syncytial virus
510(k) Number K121633
Device Name BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV
Original Applicant
Becton, Dickinson and Company
10865 road to the cure,
suite 200
san diego,  CA  92064
Original Contact gregory p payne
Regulation Number866.3480
Classification Product Code
GQG  
Date Received06/04/2012
Decision Date 09/18/2012
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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