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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 K152874
Device Name BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit
Applicant
BECTON DICKINSON, AND CO.
10865 ROAD TO THE CURE, SUITE 200
SAN DIEGO,  CA  92121
Applicant Contact GREG PAYNE
Correspondent
BECTON DICKINSON, AND CO.
10865 ROAD TO THE CURE, SUITE 200
SAN DIEGO,  CA  92121
Correspondent Contact GREG PAYNE
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received09/30/2015
Decision Date 10/27/2015
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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