Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1160](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1160) → CHS — Coulometric Method, Carbon-Dioxide

# CHS · Coulometric Method, Carbon-Dioxide

_Clinical Chemistry · 21 CFR 862.1160 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHS

## Overview

- **Product Code:** CHS
- **Device Name:** Coulometric Method, Carbon-Dioxide
- **Regulation:** [21 CFR 862.1160](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1160)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## Identification

A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

## Classification Rationale

Class II.

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K926320](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHS/K926320.md) | REFLAB SYSTEM PACK LIQUID CO2 REAGENT | Medical Analysis Systems, Inc. | Feb 3, 1993 | SESE |
| [K911838](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHS/K911838.md) | ROCHE REAGENT FOR C02 | Roche Diagnostic Systems, Inc. | Jul 19, 1991 | SESE |
| [K860660](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHS/K860660.md) | AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS | Amresco, Inc. | Mar 14, 1986 | SESE |
| [K841080](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHS/K841080.md) | TECHNICON RA-1000 SYS CO2 | Technicon Instruments Corp. | May 2, 1984 | SESE |
| [K811257](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHS/K811257.md) | CORNING 965 CARBON DIOXIDE ANALYZER | Corning Medical & Scientific | May 27, 1981 | SESE |
| [K802376](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHS/K802376.md) | KODAK EKTA-CHEM CLINICAL CHEM. SLIDES | Eastman Kodak Company | Oct 23, 1980 | SESE |

## Top Applicants

- Amresco, Inc. — 1 clearance
- Corning Medical & Scientific — 1 clearance
- Eastman Kodak Company — 1 clearance
- Medical Analysis Systems, Inc. — 1 clearance
- Roche Diagnostic Systems, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHS](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHS)

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