← Product Code [DJD](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJD) · K910527

# EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE (K910527)

_Syva Co. · DJD · Mar 14, 1991 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJD/K910527

## Device Facts

- **Applicant:** Syva Co.
- **Product Code:** [DJD](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJD.md)
- **Decision Date:** Mar 14, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3680
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJD/K910527](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJD/K910527)

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