510(k) K240984 ยท MMI Immunoassay Method, Troponin Subunit
i-STAT hs-TnI cartridge with the i-STAT 1 System
| Applicant | Abbott Point of Care, Inc., Princton NJ, US |
| Decision | Substantially Equivalent, Jan 3, 2025 |
| Received | Apr 10, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240984
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.