510(k) K202525 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 19, 2022 |
| Received | Sep 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202525
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.