510(k) K193081 ยท QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit
| Applicant | Rheonix, Inc., Ithaca NY, US |
| Decision | Substantially Equivalent, Dec 17, 2021 |
| Received | Nov 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193081
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.