510(k) K935057 ยท GJT Plasma, Coagulation Factor Deficient
FACTOR VIII DEFICIENT PLASMA
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Mar 15, 1994 |
| Received | Oct 21, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935057
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.