510(k) K941860 ยท GGN Plasma, Coagulation Control
SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Sep 14, 1994 |
| Received | Apr 15, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941860
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.