510(k) K843215 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
FACTOR IX DEFICIENT PLASMA, B9D -
| Applicant | Sigma Chemical Co., St. Louis MO, US |
| Decision | Substantially Equivalent, Nov 19, 1984 |
| Received | Aug 15, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843215
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.