510(k) DEN200070 ยท QYA System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
Simple 2 Test
| Applicant | Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.), Dun Laoghaire, IE |
| Decision | Unknown, Nov 15, 2023 |
| Received | Nov 16, 2020 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN200070
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.