K193081

Substantially Equivalent

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

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

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