← Product Code [DKJ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKJ) · K882038

# GDS ENZYMATIC SALICYLATE REAGENT (K882038)

_Gds Technology, LLC · DKJ · Jun 24, 1988 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DKJ/K882038

## Device Facts

- **Applicant:** Gds Technology, LLC
- **Product Code:** [DKJ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKJ.md)
- **Decision Date:** Jun 24, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3830
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DKJ/K882038](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DKJ/K882038)

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