510(k) K180684 ยท GJS Test, Time, Prothrombin
CoaguChek XS Plus System
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 19, 2018 |
| Received | Mar 15, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180684
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2018 | Roche Diagnostics Corporation CoaguChek XS System Prothrombin time test:
CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160;
CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160;
CoaguChek XS PT Test 24 Tests, Cat Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.