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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
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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