510(k) K934135 ยท KXT Enzyme Immunoassay, Digoxin
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION
| Applicant | Syva Co., San Jose CA, US |
| Decision | Substantially Equivalent, Apr 6, 1994 |
| Received | Aug 25, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934135
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.