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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 K232434
Device Name BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit
Applicant
BD
7 Loveton Cir.
Sparks,  MD  21152
Applicant Contact Michelle Bowerman
Correspondent
BD
7 Loveton Cir.
Sparks,  MD  21152
Correspondent Contact Michelle Bowerman
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received08/11/2023
Decision Date 12/05/2023
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
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