510(k) K034007 ยท GJT Plasma, Coagulation Factor Deficient
HEMOSIL FACTOR VIII DEFICIENT PLASMA
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Feb 13, 2004 |
| Received | Dec 24, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K034007
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.