510(k) K234143 ยท QAT Brain Trauma Assessment Test
i-STAT TBI Cartridge with the i-STAT Alinity System
| Applicant | Abbott Point of Care, Princton NJ, US |
| Decision | Substantially Equivalent, Mar 27, 2024 |
| Received | Dec 29, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234143
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.