← Product Code [DIC](/productcode/DIC) · K931516

# STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY (K931516)

_Solarcare Technologies Corp,Inc. · DIC · Jul 19, 1993 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K931516

## Device Facts

- **Applicant:** Solarcare Technologies Corp,Inc.
- **Product Code:** [DIC](/productcode/DIC.md)
- **Decision Date:** Jul 19, 1993
- **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-staging.innolitics.com/device/K931516](https://fda-staging.innolitics.com/device/K931516)

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