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 862.3670](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3670) → DJQ — Test Reagents For Phenothiazine

# DJQ · Test Reagents For Phenothiazine

_Clinical Toxicology · 21 CFR 862.3670 · Class 2_

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

## Overview

- **Product Code:** DJQ
- **Device Name:** Test Reagents For Phenothiazine
- **Regulation:** [21 CFR 862.3670](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3670)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **3rd-party reviewable:** yes

## Identification

A phenothiazine test system is a device intended to measure any of the drugs of the phenothiazine class in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenothiazine use or overdose.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K894657](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJQ/K894657.md) | POLYSTAN HEART-LUNG MACHINE SYSTEM | Polystan C/O Vitalcor, Inc. | Mar 28, 1990 | SESE |

## Top Applicants

- Polystan C/O Vitalcor, Inc. — 1 clearance

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

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