510(k) K082859 ยท GGN Plasma, Coagulation Control
HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Dec 19, 2008 |
| Received | Sep 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082859
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.