510(k) K955873 ยท LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
ACS PHENYTOIN ASSAY
| Applicant | Ciba Corning Diagnostics Corp., Medfield MA, US |
| Decision | Substantially Equivalent, Mar 11, 1996 |
| Received | Dec 26, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955873
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.