← Product Code [JKS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/JKS) · K863825

# CO-OXIMETER SOLUTIONS (K863825)

_D.R.G. Scientific Industries · JKS · Nov 24, 1986 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/JKS/K863825

## Device Facts

- **Applicant:** D.R.G. Scientific Industries
- **Product Code:** [JKS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/JKS.md)
- **Decision Date:** Nov 24, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3220
- **Device Class:** Class 1
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/JKS/K863825](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/JKS/K863825)

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