510(k) K201778 ยท QAT Brain Trauma Assessment Test
i-STAT TBI Plasma cartridge with the i-STAT Alinity System
| Applicant | Abbott Laboratories, Princton NJ, US |
| Decision | Substantially Equivalent, Jan 8, 2021 |
| Received | Jun 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201778
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.