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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 K200533
Device Name binx io CT/NG Assay and binx io CT/NG System
Applicant
binx health Inc
77 North Washington Street, 5th Floor
Boston,  MA  02114
Applicant Contact Sarah Kalil
Correspondent
binx health Inc
77 North Washington Street, 5th Floor
Boston,  MA  02114
Correspondent Contact Sarah Kalil
Regulation Number866.3393
Classification Product Code
QEP  
Subsequent Product Codes
LSL   MKZ   NSU  
Date Received03/02/2020
Decision Date 04/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT03071510
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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