510(k) K945642 ยท GHH Fibrin Split Products
AGEN DIMERTEST GOLD EIA
| Applicant | Agen Biomedical , Ltd., Brisbane, AU |
| Decision | Substantially Equivalent, Oct 25, 1995 |
| Received | Nov 16, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945642
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.