510(k) K180780 ยท GJS Test, Time, Prothrombin
microINR System
| Applicant | Iline Microsystems, S.L., Donostia-San Sebastian, ES |
| Decision | Substantially Equivalent, Jan 25, 2019 |
| Received | Mar 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180780
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.