← Product Code [DML](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML) · K840400

# EMIT ST SERUM ETHYL ALCOHOL ASSAY (K840400)

_Syva Co. · DML · Mar 23, 1984 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML/K840400

## Device Facts

- **Applicant:** Syva Co.
- **Product Code:** [DML](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML.md)
- **Decision Date:** Mar 23, 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/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML/K840400](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML/K840400)

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