510(k) K862067 ยท LFM Enzyme Immunoassay, Digitoxin
STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY
| Applicant | American Dade, Santa Ana CA, US |
| Decision | Substantially Equivalent, Jun 16, 1986 |
| Received | May 30, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862067
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.