510(k) K935375 ยท LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
AXSYM PHENYTOIN ASSAY
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 21, 1994 |
| Received | Nov 8, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935375
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.