510(k) K201185 ยท GJS Test, Time, Prothrombin
microINR System
| Applicant | Iline Microsystems, S.L., San Sebastian-Donostia, ES |
| Decision | Substantially Equivalent, Dec 18, 2020 |
| Received | May 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201185
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.