510(k) K230994 ยท MMI Immunoassay Method, Troponin Subunit
Alinity i STAT High Sensitivity Troponin-I
| Applicant | Abbott Laboratories Diagnostics Division, Abbott Park IL, US |
| Decision | Substantially Equivalent, May 4, 2023 |
| Received | Apr 7, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230994
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.