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FDA 510(k)

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

K-Number: K193081 · 2021-12-17

ApplicantRheonix, Inc.
Decision Date2021-12-17
Product CodeQEP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit is a medical device manufactured by Rheonix, Inc.. It received FDA 510(k) clearance on 2021-12-17 under approval number K193081. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit is a medical device that received FDA 510(k) clearance on 2021-12-17. It is manufactured by Rheonix, Inc.. The 510(k) number is K193081.

When was Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit approved by the FDA?

Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit received FDA 510(k) clearance on 2021-12-17, under approval number K193081.

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

Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit is manufactured by Rheonix, Inc..

What is the FDA product code for Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit?

The FDA product code for Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit is QEP.

Related Clinical Trials

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Related PubMed Literature

PMID: 37966871 Collection and Analysis of Adherence Information for Software as a Medical Device Clinical Trials: Systematic Review. JMIR mHealth and uHealth (2023)

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Official Source

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