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 862.3660](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3660) → DJH — Gas Chromatography, Phenobarbital

# DJH · Gas Chromatography, Phenobarbital

_Clinical Toxicology · 21 CFR 862.3660 · Class 2_

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

## Overview

- **Product Code:** DJH
- **Device Name:** Gas Chromatography, Phenobarbital
- **Regulation:** [21 CFR 862.3660](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3660)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **3rd-party reviewable:** yes

## Identification

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

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K843440](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJH/K843440.md) | MINGO LOG 7 | Siemens Elema AB | Sep 4, 1984 | SESE |

## Top Applicants

- Siemens Elema AB — 1 clearance

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

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