COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS
Device Facts
| Record ID | K852318 |
|---|---|
| Device Name | COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | LFT · Clinical Toxicology |
| Decision Date | Jun 25, 1985 |
| 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.
