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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 K112277
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  92064
Applicant Contact Gregory P Payne
Correspondent
Becton, Dickinson and Company
10865 ROAD TO THE CURE,
SUITE 200
SAN DIEGO,  CA  92064
Correspondent Contact Gregory P Payne
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received08/09/2011
Decision Date 10/28/2011
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
Recalls CDRH Recalls
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