← Product Code [DJQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJQ) · K894657

# POLYSTAN HEART-LUNG MACHINE SYSTEM (K894657)

_Polystan C/O Vitalcor, Inc. · DJQ · Mar 28, 1990 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJQ/K894657

## Device Facts

- **Applicant:** Polystan C/O Vitalcor, Inc.
- **Product Code:** [DJQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJQ.md)
- **Decision Date:** Mar 28, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3670
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A phenothiazine test system is a device intended to measure any of the drugs of the phenothiazine class in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenothiazine use or overdose.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJQ/K894657](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJQ/K894657)

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