510(k) K992492 ยท GJS Test, Time, Prothrombin
PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 2, 1999 |
| Received | Jul 26, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992492
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.