EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
Device Facts
| Record ID | K011347 |
|---|---|
| Device Name | EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 |
| Applicant | Syva Co. |
| Product Code | DIP · Clinical Toxicology |
| Decision Date | May 17, 2001 |
| Decision | SESE |
| Submission Type | Special |
| 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.
