510(k) K963835 ยท KXT Enzyme Immunoassay, Digoxin
DIGOXIN ENZYME IMMUNOASSAY
| Applicant | Diagnostic Reagents, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 10, 1996 |
| Received | Sep 24, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963835
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.