510(k) K940569 ยท KXT Enzyme Immunoassay, Digoxin
DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Jul 13, 1994 |
| Received | Feb 8, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940569
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.