510(k) K854638 ยท KXT Enzyme Immunoassay, Digoxin
CEDIA DIGOXIN ASSAY
| Applicant | Microgenics Corp., Concord CA, US |
| Decision | Substantially Equivalent, Mar 25, 1986 |
| Received | Nov 19, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854638
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.