PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
Device Facts
| Record ID | K943313 |
|---|---|
| Device Name | PHENYTOIN FPIA REAGENT SET AND CALIBRATORS |
| Applicant | Sigma Diagnostics, Inc. |
| Product Code | LGR · Clinical Toxicology |
| Decision Date | Oct 27, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3350 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.
