STRATUS PRIMIDONE FLOROMETRIC ENZY
Device Facts
| Record ID | K842196 |
|---|---|
| Device Name | STRATUS PRIMIDONE FLOROMETRIC ENZY |
| Applicant | American Dade |
| Product Code | LFT · Clinical Toxicology |
| Decision Date | Jul 11, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3680 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A primidone test system is a device intended to measure primidone, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of primidone overdose and in monitoring levels of primidone to ensure appropriate therapy.
