510(k) K253051 ยท MMI Immunoassay Method, Troponin Subunit
i-STAT hs-TnI cartridge with the i-STAT Alinity System
| Applicant | Abbott Point of Care, Inc., Princeton NJ, US |
| Decision | Substantially Equivalent, Jun 11, 2026 |
| Received | Sep 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253051
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.