510(k) K223187 ยท QLU Anti-Factor Xa Activity Test System, Apixaban
HemosIL Liquid Anti-Xa
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Jun 23, 2023 |
| Received | Oct 12, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223187
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.