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 862.3850](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3850) → DKW — Test Reagents For Sulphanimide Derivatives

# DKW · Test Reagents For Sulphanimide Derivatives

_Clinical Toxicology · 21 CFR 862.3850 · Class 1_

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

## Overview

- **Product Code:** DKW
- **Device Name:** Test Reagents For Sulphanimide Derivatives
- **Regulation:** [21 CFR 862.3850](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3850)
- **Device Class:** 1
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **3rd-party reviewable:** yes

## Identification

A sulfonamide test system is a device intended to measure sulfonamides, any of the antibacterial drugs derived from sulfanilamide, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of sulfonamide overdose and in monitoring sulfonamide levels to ensure appropriate therapy.

## Classification Rationale

Class I.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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