510(k) K972288 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
FACTOR DEFICIENT PLASMAS - FACTOR IX (9)
| Applicant | Universal Reagents, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 14, 1997 |
| Received | Jun 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972288
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.