← Product Code [LFT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFT) · K842196

# STRATUS PRIMIDONE FLOROMETRIC ENZY (K842196)

_American Dade · LFT · Jul 11, 1984 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFT/K842196

## Device Facts

- **Applicant:** American Dade
- **Product Code:** [LFT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFT.md)
- **Decision Date:** Jul 11, 1984
- **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/LFT/K842196](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFT/K842196)

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