Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit— 510(k) K193081
Substantially EquivalentRheonix, 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..
Clearance details
- Applicant
- Rheonix, Inc.
- Product code
- Code QEP
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ithaca, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.