510(k) K102346 ยท KXT Enzyme Immunoassay, Digoxin
RANDOX DIGOXIN ASSAY
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Oct 14, 2011 |
| Received | Aug 19, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102346
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.