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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name antigens, cf (including cf control), influenza virus a, b, c
510(K) Number K121797
Device Name BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
Applicant
BECTON, DICKINSON AND COMPANY
10865 road to the cure,
suite 200
san diego,  CA  92121
Contact gregory p payne, rac
Regulation Number866.3330
Classification Product Code
GNX  
Date Received06/19/2012
Decision Date 09/07/2012
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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