← Product Code [DPE](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DPE) · K791979

# TECHNICON FAST-LC SYS. ANTICONVU DRUGS (K791979)

_Technicon Instruments Corp. · DPE · Nov 13, 1979 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DPE/K791979

## Device Facts

- **Applicant:** Technicon Instruments Corp.
- **Product Code:** [DPE](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DPE.md)
- **Decision Date:** Nov 13, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3350
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DPE/K791979](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DPE/K791979)

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