510(k) K812431 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
FACTOR VIII DEFICIENT PLASMA #B8D
| Applicant | Sigma Chemical Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 23, 1981 |
| Received | Aug 25, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812431
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.