510(k) K222379 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, Mar 3, 2023 |
| Received | Aug 5, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222379
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2024 | Abbott Molecular, Inc. Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091; Open, Classified |
QEP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.