510(k) K243543 ยท GJS Test, Time, Prothrombin
microINR System
| Applicant | Iline Microsystems, S.L., San Sebastian-Donostia, ES |
| Decision | Substantially Equivalent, Feb 27, 2025 |
| Received | Nov 15, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243543
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.