Rheonix STI Tri-Plex Assay, Rheonix EncompassMDx Workstation (instrument And Software), Rheonix Urine Specimen Collection Kit, Rheonix Swab Specimen Collection Kit

Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections

Rheonix, Inc

The following data is part of a premarket notification filed by Rheonix, Inc with the FDA for Rheonix Sti Tri-plex Assay, Rheonix Encompassmdx Workstation (instrument And Software), Rheonix Urine Specimen Collection Kit, Rheonix Swab Specimen Collection Kit.

Pre-market Notification Details

Device IDK193081
510k NumberK193081
Device Name:Rheonix STI Tri-Plex Assay, Rheonix EncompassMDx Workstation (instrument And Software), Rheonix Urine Specimen Collection Kit, Rheonix Swab Specimen Collection Kit
ClassificationNucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Applicant Rheonix, Inc 10 Brown Road, Suite 103 Ithaca,  NY  14850
ContactRichard Montagna
CorrespondentRichard Montagna
Rheonix, Inc 2680 Grand Island Boulevard, Suite 1 Grand Island,  NY  14072
Product CodeQEP  
Subsequent Product CodeLSL
Subsequent Product CodeMKZ
Subsequent Product CodeNSU
Subsequent Product CodeOUY
CFR Regulation Number866.3393 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-05
Decision Date2021-12-17

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