510(k) K834050 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
PROTOPATH FACTOR IX ASSAY
| Applicant | American Dade, Walker MI, US |
| Decision | Substantially Equivalent, Feb 4, 1984 |
| Received | Nov 23, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K834050
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.