510(k) K220282 ยท GJS Test, Time, Prothrombin
i-STAT PTplus Cartridge with the i-STAT 1 System
| Applicant | Abbott Laboratories, Princton NJ, US |
| Decision | Substantially Equivalent, Jul 14, 2023 |
| Received | Feb 1, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220282
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.