510(k) K943500 ยท KXT Enzyme Immunoassay, Digoxin
EMIT 2000 DIGOXIN ASSAY
| Applicant | Syva Co., San Jose CA, US |
| Decision | Substantially Equivalent, Nov 15, 1994 |
| Received | Jul 5, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943500
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.