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) → DOZ — Liquid Chromatography, Diphenylhydantoin

# DOZ · Liquid 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/DOZ

## Overview

- **Product Code:** DOZ
- **Device Name:** Liquid 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 |
| --- | --- | --- | --- | --- |
| [K781941](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOZ/K781941.md) | ANALYSIS SYSTEM, PREP SAMPLE | E.I. Dupont DE Nemours & Co., Inc. | Jan 3, 1979 | SESE |

## Top Applicants

- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com