510(k) K982935 ยท KXT Enzyme Immunoassay, Digoxin
SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Oct 14, 1998 |
| Received | Aug 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982935
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.