510(k) K963158 ยท LFM Enzyme Immunoassay, Digitoxin
ABBOTT AXSYM DIGITOXIN (MODIFY)
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Sep 10, 1996 |
| Received | Jul 26, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963158
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.