510(k) K790521 ยท KXT Enzyme Immunoassay, Digoxin
OREIA - DIGOXIN
| Applicant | Organon, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 10, 1979 |
| Received | Mar 16, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K790521
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.