510(k) K093848 ยท GGN Plasma, Coagulation Control
PT-MULTI-CALIBRATOR, MODEL OPAT07
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Dec 20, 2010 |
| Received | Dec 16, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093848
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.