510(k) K063823 ยท GGN Plasma, Coagulation Control
COAGUCHEK XS PT CONTROLS
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 29, 2007 |
| Received | Dec 26, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063823
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.