510(k) K760800 ยท DON Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
SPAC DIGOXIN KIT
| Applicant | Mallinckrodt Critical Care, Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 1, 1976 |
| Received | Oct 8, 1976 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K760800
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.