← Product Code [JKS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/JKS) · K853990

# OSM3 HEMOXIMETER (K853990)

_Radiometer America, Inc. · JKS · Dec 30, 1985 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/JKS/K853990

## Device Facts

- **Applicant:** Radiometer America, Inc.
- **Product Code:** [JKS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/JKS.md)
- **Decision Date:** Dec 30, 1985
- **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/K853990](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/JKS/K853990)

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