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) → LFO — Nephelometric Inhibition Immunoassay, Diphenylhydantoin

# LFO · Nephelometric Inhibition Immunoassay, 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/LFO

## Overview

- **Product Code:** LFO
- **Device Name:** Nephelometric Inhibition Immunoassay, 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 |
| --- | --- | --- | --- | --- |
| [K880294](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFO/K880294.md) | DART PHENYTOIN | Coulter Electronics, Inc. | May 27, 1988 | SESE |

## Top Applicants

- Coulter Electronics, Inc. — 1 clearance

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

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