510(k) K913240 ยท LFM Enzyme Immunoassay, Digitoxin
DIGITOXIN (FPIA) KIT
| Applicant | Tudor Laboratories, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Sep 6, 1991 |
| Received | Jul 22, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913240
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.