510(k) K970593 ยท GJT Plasma, Coagulation Factor Deficient
UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA
| Applicant | Universal Reagents, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 25, 1997 |
| Received | Feb 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970593
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.