Browse hierarchy: [Clinical Toxicology (TX)](/submissions/TX) → [Subpart D — Clinical Toxicology Test Systems](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems) → [21 CFR 862.3350](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3350) → DPE — Thin Layer Chromatography, Diphenylhydantoin

# DPE · Thin Layer Chromatography, Diphenylhydantoin

_Clinical Toxicology · 21 CFR 862.3350 · Class 2_

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

## Overview

- **Product Code:** DPE
- **Device Name:** Thin Layer Chromatography, Diphenylhydantoin
- **Regulation:** [21 CFR 862.3350](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3350)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K791979](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DPE/K791979.md) | TECHNICON FAST-LC SYS. ANTICONVU DRUGS | Technicon Instruments Corp. | Nov 13, 1979 | SESE |

## Top Applicants

- Technicon Instruments Corp. — 1 clearance

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

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