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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 K132693
Device Name BD Veritor™ System Flu A+B Assay
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 Received08/29/2013
Decision Date 10/02/2013
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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