510(k) K993026 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS
| Applicant | Syva Co., San Jose CA, US |
| Decision | Substantially Equivalent, Jan 27, 2000 |
| Received | Sep 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993026
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | Abbott Laboratories Inc. ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation of phenytoin in human serum or plasma. Terminated |
DIP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.