510(k) K954420 ยท LFM Enzyme Immunoassay, Digitoxin
AXSYM DIGITOXIN
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Dec 29, 1995 |
| Received | Sep 21, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954420
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.