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) → CIL — Cresol Red Colorimetry, Carbon-Dioxide

# CIL · Cresol Red Colorimetry, 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/CIL

## Overview

- **Product Code:** CIL
- **Device Name:** Cresol Red Colorimetry, 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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K922953](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIL/K922953.md) | SYSTEMATE CALCIUM TEST TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | Sep 9, 1992 | SESE |
| [K895880](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIL/K895880.md) | PANCREATIC A-AMYLASE EPS | Boehringer Mannheim Corp. | Dec 19, 1989 | SESE |
| [K833724](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIL/K833724.md) | ENZYMATIC CO2 | American Monitor Corp. | Dec 29, 1983 | SESE |
| [K800111](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIL/K800111.md) | CO2 CONTENT | American Monitor Corp. | Feb 13, 1980 | SESE |

## Top Applicants

- American Monitor Corp. — 2 clearances
- Boehringer Mannheim Corp. — 1 clearance
- Em Diagnostic Systems, Inc. — 1 clearance

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

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