STRATUS PHENYTOIN FLUOROMETRIC ENZYME
Device Facts
| Record ID | K831154 |
|---|---|
| Device Name | STRATUS PHENYTOIN FLUOROMETRIC ENZYME |
| Applicant | American Dade |
| Product Code | LES · Clinical Toxicology |
| Decision Date | May 16, 1983 |
| 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.
