CENTRIA PHENYTOIN RIA TEST SET
Device Facts
| Record ID | K791896 |
|---|---|
| Device Name | CENTRIA PHENYTOIN RIA TEST SET |
| Applicant | Ventrex Laboratories, Inc. |
| Product Code | DLP · Clinical Toxicology |
| Decision Date | Oct 17, 1979 |
| 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.
