← Product Code [DML](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML) · K840769

# PARAMAX ALCOHOL REAGENT (K840769)

_American Dade · DML · Apr 13, 1984 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DML/K840769

## Device Facts

- **Applicant:** American Dade
- **Product Code:** [DML](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML.md)
- **Decision Date:** Apr 13, 1984
- **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/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DML/K840769](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DML/K840769)

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