510(k) K943313 ยท LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Oct 27, 1994 |
| Received | Jul 11, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943313
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.