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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
7loveton Cir
Sparks,  MD  21152
Applicant Contact Michelle Bowerman
Correspondent
Bd
7loveton 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
Predetermined Change
Control Plan Authorized		 No
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