← Product Code [DIE](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIE) · K891691

# LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II (K891691)

_Bio-Rad · DIE · Dec 19, 1989 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIE/K891691

## Device Facts

- **Applicant:** Bio-Rad
- **Product Code:** [DIE](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIE.md)
- **Decision Date:** Dec 19, 1989
- **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/DIE/K891691](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIE/K891691)

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