510(k) K850712 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY
| Applicant | Syva Co., Palo Alto CA, US |
| Decision | Substantially Equivalent, Mar 20, 1985 |
| Received | Feb 22, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850712
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.