510(k) K092940 ยท GJS Test, Time, Prothrombin
COAGUCHEK XS PLUS PST SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 5, 2010 |
| Received | Sep 24, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092940
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.