Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit— 510(k) K193081

Name: FDA 510(k) clearance K193081
Creator: U.S. Food and Drug Administration
Published: 2021-12-17

Substantially Equivalent

Rheonix, Inc.

FDA 510(k) clearance K193081 for Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit, Substantially Equivalent on 2021-12-17. Applicant: Rheonix, Inc.. Device class: 2.

Clearance details

Applicant: Rheonix, Inc.
Product code: Product code QEP
Device class: Class 2
Regulation: 21 CFR 866.3393
Advisory panel: Microbiology
Date received: 2019-11-05
Decision date: 2021-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ithaca, NY, US

Download summary PDF View on FDA.gov ↗

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