510(k) K952321 ยท GGN Plasma, Coagulation Control
PORCINE FACTOR VIII;C REAGENT
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Mar 11, 1996 |
| Received | May 18, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952321
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.