510(k) K944085 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
ACE(TM) CEDIA(R) PHENYTOIN ASSAY
| Applicant | Schiapparelli Biosystems, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Dec 28, 1994 |
| Received | Aug 22, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944085
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.