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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 K191352
FOIA Releasable 510(k) K191352
Device Name binx health io CT/NG Assay
Applicant
Binx Health, Inc.
77 N. Washington St., 5th Floor
Boston,  MA  02114
Applicant Contact Sarah Kalil
Correspondent
Binx Health, Inc.
77 N. Washington St., 5th Floor
Boston,  MA  02114
Correspondent Contact Sarah Kalil
Classification Product Code
QEP  
Subsequent Product Codes
LSL   MKZ   NSU  
Date Received05/20/2019
Decision Date 08/08/2019
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
Predetermined Change
Control Plan Authorized		 No
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