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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections
510(k) Number K210585
Device Name BD CTGCTV2
Applicant
Becton Dickinson and Company
7 Loveton Circle
Sparks,  MD  21152
Applicant Contact Sue Werner
Correspondent
Becton Dickinson and Company
7 Loveton Circle
Sparks,  MD  21152
Correspondent Contact Jessica Dewyer
Regulation Number866.3393
Classification Product Code
QEP  
Subsequent Product Codes
LSL   MKZ   OUY  
Date Received02/26/2021
Decision Date 05/10/2022
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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