← Product Code [DKJ](/productcode/DKJ) · K813185

# SALICYLATE STAT-PAK (K813185)

_Clin Tech Diagnostics Corp. · DKJ · Nov 24, 1981 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K813185

## Device Facts

- **Applicant:** Clin Tech Diagnostics Corp.
- **Product Code:** [DKJ](/productcode/DKJ.md)
- **Decision Date:** Nov 24, 1981
- **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-staging.innolitics.com/device/K813185](https://fda-staging.innolitics.com/device/K813185)

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