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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 K180438
Device Name BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
Applicant
Bd
10865 Rd. To The Cure
San Diego,  CA  92121
Applicant Contact Brad Spring
Correspondent
Bd
10865 Rd. To The Cure,
Suite 200
San Diego,  CA  92121
Correspondent Contact Mary Ann Fiechtner
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received02/20/2018
Decision Date 03/20/2018
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
Recalls CDRH Recalls
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