510(k) K950280 ยท MOJ Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)
TDX(R)/TDXFLX(R) FREE PHENYTOIN II
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, May 2, 1995 |
| Received | Jan 24, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950280
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.