510(k) K884054 ยท KXT Enzyme Immunoassay, Digoxin
MODIFICATION OF THE CEDIA DIGOXIN ASSAY
| Applicant | Microgenics Corp., Concord CA, US |
| Decision | Substantially Equivalent, Dec 2, 1988 |
| Received | Sep 26, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884054
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.