510(k) K911941 ยท KXT Enzyme Immunoassay, Digoxin
CEDIA(R) DIGOXIN R' ASSAY
| Applicant | Microgenics Corp., Concord CA, US |
| Decision | Substantially Equivalent, May 15, 1991 |
| Received | May 1, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911941
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.