510(k) K864802 ยท LCS Radioimmunoassay, Digoxin (125-I)
DART DIGOXIN ASSAY
| Applicant | Coulter Electronics, Inc., Hialeah FL, US |
| Decision | Substantially Equivalent, Feb 12, 1987 |
| Received | Dec 9, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864802
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.