510(k) K943983 ยท KXT Enzyme Immunoassay, Digoxin
IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS
| Applicant | Instrumentation Laboratory CO, Lexington MA, US |
| Decision | Substantially Equivalent, Apr 10, 1995 |
| Received | Jun 7, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943983
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.