510(k) K844171 ยท LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Walker MI, US |
| Decision | Substantially Equivalent, Dec 10, 1984 |
| Received | Oct 25, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K844171
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.