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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
510(k) Number K132456
Device Name BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV
Applicant
Becton, Dickinson and Company
10865 Rd. To The Cure,
Suite 200
San Diego,  CA  92121
Applicant Contact GREGORY P PAYNE, RAC
Correspondent
Becton, Dickinson and Company
10865 Rd. To The Cure,
Suite 200
San Diego,  CA  92121
Correspondent Contact GREGORY P PAYNE, RAC
Regulation Number866.3480
Classification Product Code
GQG  
Date Received08/06/2013
Decision Date 11/07/2013
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
Predetermined Change
Control Plan Authorized		 No
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