510(k) K861195 ยท KXT Enzyme Immunoassay, Digoxin
DELFIA DIGOXIN
| Applicant | Lkb Instruments, Inc., Gaithersburg MD, US |
| Decision | Substantially Equivalent, Jul 11, 1986 |
| Received | Mar 31, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861195
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.