510(k) K946328 ยท LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
TDX(R)/TDXFLX(R) PHENYTOIN II
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Mar 28, 1995 |
| Received | Dec 29, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946328
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.