510(k) K864333 ยท KXT Enzyme Immunoassay, Digoxin
DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY
| Applicant | Windsor Laboratories, Inc., Garland TX, US |
| Decision | Substantially Equivalent, Jan 5, 1987 |
| Received | Nov 4, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864333
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.