510(k) K862554 ยท LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
IMMPULSE PHENYTOIN ASSAY REAGENT
| Applicant | Sclavo, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jul 16, 1986 |
| Received | Jul 3, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862554
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.