510(k) K202977 ยท QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Alinity m STI Assay
| Applicant | Abbott Molecular, Inc., Des Plaines IL, US |
| Decision | Substantially Equivalent, Apr 29, 2022 |
| Received | Sep 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202977
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.