← Product Code [DML](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML) · K952839

# BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY (K952839)

_Boehringer Mannheim Corp. · DML · Aug 24, 1995 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML/K952839

## Device Facts

- **Applicant:** Boehringer Mannheim Corp.
- **Product Code:** [DML](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML.md)
- **Decision Date:** Aug 24, 1995
- **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/DML/K952839](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML/K952839)

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