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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
510(k) Number K261379
Device Name BD Veritor System for SARS-CoV-2
Applicant
BD Diagnostic Solutions / Becton, Dickinson & Company
7 Loveton Cir.
Sparks,  MD  21152
Applicant Contact David Lee
Correspondent
BD Diagnostic Solutions / Becton, Dickinson & Company
7 Loveton Cir.
Sparks,  MD  21152
Correspondent Contact David Lee
Classification Product Code
QVF  
Date Received04/27/2026
Decision Date 10/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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