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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 K133138
Device Name BD Veritor™ System Flu A+B Assay
Applicant
Becton, Dickinson & CO
10865 Rd. To The Cure,
Suite 200
San Diego,  CA  92121
Applicant Contact Gregory P Payne
Correspondent
Becton, Dickinson & CO
10865 Rd. To The Cure,
Suite 200
San Diego,  CA  92121
Correspondent Contact Gregory P Payne
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received10/17/2013
Decision Date 11/13/2013
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
Predetermined Change
Control Plan Authorized		 No
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