510(k) K842586 ยท LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
PHENYTOIN KIT FLUORESCENCE POLARIZATION
| Applicant | Windsor Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 26, 1984 |
| Received | Jul 3, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K842586
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.