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) → CIE — Volumetric/Manometric, Carbon-Dioxide

# CIE · Volumetric/Manometric, 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/CIE

## Overview

- **Product Code:** CIE
- **Device Name:** Volumetric/Manometric, 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 (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K904761](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIE/K904761.md) | P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT | Instrumentation Laboratory CO | Nov 20, 1990 | SESE |
| [K880967](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIE/K880967.md) | MICRO CO2 APPARATUS | Hf Scientific, Inc. | Apr 28, 1988 | SESE |
| [K864313](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIE/K864313.md) | CO2 REAGENT SET | Hf Scientific, Inc. | Mar 13, 1987 | SESE |
| [K832071](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIE/K832071.md) | TOTAL CO2 REAGENT SET | American Research Products Co. | Aug 11, 1983 | SESE |
| [K820091](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIE/K820091.md) | AIRMED SMOKE EVACUATION & FILTER | James L. Geraci & Associates, Inc. | Feb 24, 1982 | SESE |
| [K800524](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIE/K800524.md) | SERALYZER REFLECTANCE PHOTOMETER/CALIB. | Miles Laboratories, Inc. | Apr 2, 1980 | SESE |
| [K771610](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIE/K771610.md) | CARBON DIOXIDE ANALYZER | Corning Medical & Scientific | Oct 7, 1977 | SESE |

## Top Applicants

- Hf Scientific, Inc. — 2 clearances
- American Research Products Co. — 1 clearance
- Corning Medical & Scientific — 1 clearance
- Instrumentation Laboratory CO — 1 clearance
- James L. Geraci & Associates, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com