510(k) K983151 ยท KXT Enzyme Immunoassay, Digoxin
IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Nov 5, 1998 |
| Received | Sep 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983151
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.