510(k) K914151 ยท KXT Enzyme Immunoassay, Digoxin
IL TEST(TM DIGOXIN
| Applicant | Instrumentation Laboratory CO, Lexington MA, US |
| Decision | Substantially Equivalent, Nov 29, 1991 |
| Received | Sep 16, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914151
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.