510(k) K082953 ยท KXT Enzyme Immunoassay, Digoxin
ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
| Applicant | Biokit, S.A., Barcelona, ES |
| Decision | Substantially Equivalent, Dec 22, 2008 |
| Received | Oct 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082953
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.