← Product Code [LAS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS) · K921939

# SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) (K921939)

_Heraeus Kulzer, Inc. · LAS · Jul 16, 1992 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K921939

## Device Facts

- **Applicant:** Heraeus Kulzer, Inc.
- **Product Code:** [LAS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS.md)
- **Decision Date:** Jul 16, 1992
- **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/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K921939](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K921939)

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