← Product Code [DIC](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC) · K001286

# ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 (K001286)

_Diagnostic Chemicals , Ltd. · DIC · Jun 20, 2000 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K001286

## Device Facts

- **Applicant:** Diagnostic Chemicals , Ltd.
- **Product Code:** [DIC](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC.md)
- **Decision Date:** Jun 20, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3040
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K001286](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K001286)

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