← Product Code [LFT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFT) · K852318

# COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS (K852318)

_Roche Diagnostic Systems, Inc. · LFT · Jun 25, 1985 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFT/K852318

## Device Facts

- **Applicant:** Roche Diagnostic Systems, Inc.
- **Product Code:** [LFT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFT.md)
- **Decision Date:** Jun 25, 1985
- **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/K852318](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFT/K852318)

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