← Product Code [LAX](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAX) · K823865

# ADVANCE SYS. EMIT-CAD LIDOCAINE CONTROL (K823865)

_Syva Co. · LAX · Jan 14, 1983 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LAX/K823865

## Device Facts

- **Applicant:** Syva Co.
- **Product Code:** [LAX](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAX.md)
- **Decision Date:** Jan 14, 1983
- **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/LAX/K823865](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LAX/K823865)

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