510(k) K771638 ยท DPO Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
IGOXIN SOLID PHASE RIA
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Washington DC, US |
| Decision | Substantially Equivalent, Oct 7, 1977 |
| Received | Aug 26, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K771638
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.