← Product Code [LFT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFT) · K904683

# STRATUS PRIMIDONE FLUOROMETRIC ENZYME (K904683)

_Baxter Healthcare Corp · LFT · Nov 28, 1990 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LFT/K904683

## Device Facts

- **Applicant:** Baxter Healthcare Corp
- **Product Code:** [LFT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFT.md)
- **Decision Date:** Nov 28, 1990
- **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/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LFT/K904683](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LFT/K904683)

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