← Product Code [DKJ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKJ) · K861615

# SALICYLATE REAGENT SET (K861615)

_Sterling Diagnostics, Inc. · DKJ · May 23, 1986 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKJ/K861615

## Device Facts

- **Applicant:** Sterling Diagnostics, Inc.
- **Product Code:** [DKJ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKJ.md)
- **Decision Date:** May 23, 1986
- **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/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKJ/K861615](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKJ/K861615)

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