510(k) K915465 ยท LFM Enzyme Immunoassay, Digitoxin
DIGITOXIN FPIA REAGENT SET
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Jan 27, 1992 |
| Received | Dec 2, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915465
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.