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 862.3830](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3830) → DJE — Thin Layer Chromatography, Salicylate

# DJE · Thin Layer Chromatography, Salicylate

_Clinical Toxicology · 21 CFR 862.3830 · Class 2_

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

## Overview

- **Product Code:** DJE
- **Device Name:** Thin Layer Chromatography, Salicylate
- **Regulation:** [21 CFR 862.3830](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3830)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **3rd-party reviewable:** yes

## Identification

A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K802615](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJE/K802615.md) | EMIT-STM OPIATE ASSAY | Syva Co. | Oct 31, 1980 | SESE |

## Top Applicants

- Syva Co. — 1 clearance

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

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