510(k) K880292 ยท GJT Plasma, Coagulation Factor Deficient
FACTOR VIII REFERENCE PLASMA
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Feb 19, 1988 |
| Received | Jan 25, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880292
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.