← Product Code [DKC](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKC) · K843872

# ETHANOL CONTROLS LOW & HIGH E5133/E5258 (K843872)

_Sigma Chemical Co. · DKC · Oct 31, 1984 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DKC/K843872

## Device Facts

- **Applicant:** Sigma Chemical Co.
- **Product Code:** [DKC](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKC.md)
- **Decision Date:** Oct 31, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3280
- **Device Class:** Class 1
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DKC/K843872](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DKC/K843872)

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