510(k) K963840 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
CEDIA PHENYTOIN II ASSAY
| Applicant | Boehringer Mannheim Corp., Concord CA, US |
| Decision | Substantially Equivalent, Nov 20, 1996 |
| Received | Sep 24, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963840
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.