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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name vaginitis and bacterial vaginosis nucleic acid detection system
510(k) Number K223653
Device Name BD Vaginal Panel
Applicant
Becton, Dickinson and Company
7 Loveton Circle
Sparks,  MD  21152
Applicant Contact Joseph Basore
Correspondent
Becton, Dickinson and Company
7 Loveton Circle
Sparks,  MD  21152
Correspondent Contact Joseph Basore
Regulation Number866.3975
Classification Product Code
PQA  
Subsequent Product Codes
NSU   OOI   OUY  
Date Received12/06/2022
Decision Date 03/06/2023
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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