← Product Code [DIE](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIE) · K863915

# SHAPE-ACTIO METAL TOXICOLOGY CONTROL (K863915)

_Shape Products Co. · DIE · Nov 24, 1986 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIE/K863915

## Device Facts

- **Applicant:** Shape Products Co.
- **Product Code:** [DIE](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIE.md)
- **Decision Date:** Nov 24, 1986
- **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/K863915](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIE/K863915)

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