← Product Code [JKS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/JKS) · K780652

# HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 (K780652)

_The London Co. · JKS · Jul 27, 1978 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-d%E2%80%94clinical-toxicology-test-systems/JKS/K780652

## Device Facts

- **Applicant:** The London Co.
- **Product Code:** [JKS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/JKS.md)
- **Decision Date:** Jul 27, 1978
- **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/HE/subpart-d%E2%80%94clinical-toxicology-test-systems/JKS/K780652](https://fda.innolitics.com/submissions/HE/subpart-d%E2%80%94clinical-toxicology-test-systems/JKS/K780652)

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