510(k) K050661 ยท GJT Plasma, Coagulation Factor Deficient
HEMOSIL FACTOR II DEFICIENT PLASMA
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, May 2, 2005 |
| Received | Mar 15, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050661
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.