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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 K193081
Device Name Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit
Applicant
Rheonix, Inc
10 Brown Road, Suite 103
Ithaca,  NY  14850
Applicant Contact Richard Montagna
Correspondent
Rheonix, Inc
2680 Grand Island Boulevard, Suite 1
Grand Island,  NY  14072
Correspondent Contact Richard Montagna
Classification Product Code
QEP  
Subsequent Product Codes
LSL   MKZ   NSU   OUY  
Date Received11/05/2019
Decision Date 12/17/2021
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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