510(k) K811745 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
VIRGO IPA FOR DETECTION OF PHENYTOIN
| Applicant | Electro-Nucleonics Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 10, 1981 |
| Received | Jun 19, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811745
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.