510(k) K831177 ยท KXT Enzyme Immunoassay, Digoxin
STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-
| Applicant | American Dade, Walker MI, US |
| Decision | Substantially Equivalent, May 17, 1983 |
| Received | Apr 11, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831177
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.