← Product Code [LFT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFT) · K950028

# PRIMIDONE FPIA REAGENT SET AND CALIBRATORS (K950028)

_Sigma Diagnostics, Inc. · LFT · Mar 21, 1995 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFT/K950028

## Device Facts

- **Applicant:** Sigma Diagnostics, Inc.
- **Product Code:** [LFT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFT.md)
- **Decision Date:** Mar 21, 1995
- **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/K950028](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFT/K950028)

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