510(k) K011393 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
RANDOX PHENYTOIN
| Applicant | Randox Laboratories, Ltd., Crumlin, Co. Antrim, IE |
| Decision | Substantially Equivalent, Dec 4, 2001 |
| Received | May 7, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011393
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2014 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2-pack
SMN 10311391
For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVI Terminated |
DIP | None listed |
| Feb 4, 2014 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 6-pack
SMN 10314977
For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADV Terminated |
DIP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.