510(k) K180693 ยท GJS Test, Time, Prothrombin
CoaguChek XS Pro System
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 19, 2018 |
| Received | Mar 16, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180693
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.