510(k) K243410 ยท QYA System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
simpli-COLLECT STI Test
| Applicant | Abbott Molecular, Des Plaines IL, US |
| Decision | Substantially Equivalent, Jan 30, 2025 |
| Received | Nov 1, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243410
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.