510(k) K931213 ยท KXT Enzyme Immunoassay, Digoxin
ACS DIGOXIN IMMUNOASSAY
| Applicant | Ciba Corning Diagnostics Corp., East Walpole MA, US |
| Decision | Substantially Equivalent, Jun 7, 1993 |
| Received | Mar 10, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931213
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.