510(k) K853461 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA
| Applicant | American Dade, Santa Ana CA, US |
| Decision | Substantially Equivalent, Aug 29, 1985 |
| Received | Aug 19, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853461
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.