510(k) K011302 ยท KXT Enzyme Immunoassay, Digoxin
RANDOX DIGOXIN
| Applicant | Randox Laboratories, Ltd., Crumlin, Co. Antrim, IE |
| Decision | Substantially Equivalent, Jul 2, 2001 |
| Received | Apr 30, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011302
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.