AMES TDA PRIMIDONE TEST
Device Facts
| Record ID | K802654 |
|---|---|
| Device Name | AMES TDA PRIMIDONE TEST |
| Applicant | Miles Laboratories, Inc. |
| Product Code | DJD · Clinical Toxicology |
| Decision Date | Nov 12, 1980 |
| 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.
