510(k) K861048 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765
| Applicant | Sigma Chemical Co., St. Louis MO, US |
| Decision | Substantially Equivalent, May 29, 1986 |
| Received | Mar 19, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861048
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.