510(k) K011347 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
| Applicant | Syva Co., San Jose CA, US |
| Decision | Substantially Equivalent, May 17, 2001 |
| Received | May 2, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011347
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.