510(k) K972794 ยท KXT Enzyme Immunoassay, Digoxin
DIGOXIN DG-II FPIA REAGENT SET
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Jul 31, 1997 |
| Received | Jun 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972794
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.