← Product Code [DIC](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC) · K010960

# EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 (K010960)

_Syva Co., Dade Behring, Inc. · DIC · Apr 26, 2001 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K010960

## Device Facts

- **Applicant:** Syva Co., Dade Behring, Inc.
- **Product Code:** [DIC](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC.md)
- **Decision Date:** Apr 26, 2001
- **Decision:** SESE
- **Submission Type:** Special
- **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/DIC/K010960](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K010960)

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