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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name devices detecting influenza a, b, and c virus antigens
510(k) Number K132256
Device Name BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
Applicant
Becton, Dickinson and Company
10865 ROAD TO THE CURE
SUITE 200
SAN DIEGO,  CA  92121
Applicant Contact GREGORY P PAYNE, RAC
Correspondent
Becton, Dickinson and Company
10865 ROAD TO THE CURE
SUITE 200
SAN DIEGO,  CA  92121
Correspondent Contact GREGORY P PAYNE, RAC
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received07/19/2013
Decision Date 08/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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