510(k) K925802 ยท KXT Enzyme Immunoassay, Digoxin
ACCESS DIGOXIN ASSAY
| Applicant | Bio-Rad Laboratories, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jan 13, 1993 |
| Received | Nov 16, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925802
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2005 | Beckman Coulter Inc Access Immunoasay Systems Digoxin Reagent Terminated |
KXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.