510(k) K964459 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA
| Applicant | Universal Reagents, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 18, 1996 |
| Received | Nov 7, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964459
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.