510(k) K946153 ยท KXT Enzyme Immunoassay, Digoxin
DIGOXIN FLEX(TM) REAGENT CARTRIDGE
| Applicant | E.I. Dupont DE Nemours & Co., Inc., Wilmington DE, US |
| Decision | Substantially Equivalent, Feb 22, 1995 |
| Received | Dec 16, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946153
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.