510(k) K870953 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
PHENYTOIN FPIA REAGENT SET
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Mar 31, 1987 |
| Received | Mar 10, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870953
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.