510(k) K802358 ยท KXT Enzyme Immunoassay, Digoxin
OREIA-Q-DIG
| Applicant | Organon, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 10, 1980 |
| Received | Sep 26, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K802358
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.