510(k) K911056 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD
| Applicant | E.I. Dupont DE Nemours & Co., Inc., Wilmington DE, US |
| Decision | Substantially Equivalent, Apr 3, 1991 |
| Received | Mar 8, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911056
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2014 | Siemens Healthcare Diagnostics, Inc. siemens Dimension Phenytoin Flex Reagent Cartridge
The PTN method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydan Terminated |
DIP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.