← Product Code [DML](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML) · K914777

# SIGMA PROCEDURE NO. 333-UV (K914777)

_Sigma Diagnostics, Inc. · DML · Dec 27, 1991 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML/K914777

## Device Facts

- **Applicant:** Sigma Diagnostics, Inc.
- **Product Code:** [DML](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML.md)
- **Decision Date:** Dec 27, 1991
- **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/K914777](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DML/K914777)

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