PRIMIDONE FPIA REAGENT SET AND CALIBRATORS
Device Facts
| Record ID | K950028 |
|---|---|
| Device Name | PRIMIDONE FPIA REAGENT SET AND CALIBRATORS |
| Applicant | Sigma Diagnostics, Inc. |
| Product Code | LFT · Clinical Toxicology |
| Decision Date | Mar 21, 1995 |
| 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.
