← Product Code [DML](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML) · K863419

# EMDS(TM) ALCOHOL TESTPACKS, #67691/95 (K863419)

_Em Diagnostic Systems, Inc. · DML · Sep 29, 1986 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML/K863419

## Device Facts

- **Applicant:** Em Diagnostic Systems, Inc.
- **Product Code:** [DML](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML.md)
- **Decision Date:** Sep 29, 1986
- **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/K863419](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML/K863419)

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