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) → KMS — Phenolphthalein Colorimetry, Carbon-Dioxide

# KMS · Phenolphthalein 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/KMS

## Overview

- **Product Code:** KMS
- **Device Name:** Phenolphthalein 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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K872886](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KMS/K872886.md) | CARBON DIOXIDE | Catachem, Inc. | Aug 13, 1987 | SESE |
| [K870025](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KMS/K870025.md) | AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS | American Research Products Co. | Mar 13, 1987 | SESE |
| [K802162](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KMS/K802162.md) | CO2 COLOR REAGENT & CO2 SAMPLE DILUENT | Panmed, Inc. | Oct 10, 1980 | SESE |
| [K800681](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KMS/K800681.md) | REAGENTS FOR DETERM. CO2 IN HUMAN SERUM | Diagnostic Solutions, Inc. | May 30, 1980 | SESE |
| [K780506](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KMS/K780506.md) | CARBON DIOXIDE REAGENTS | Gamma Enterprises, Inc. | May 3, 1978 | SESE |

## Top Applicants

- American Research Products Co. — 1 clearance
- Catachem, Inc. — 1 clearance
- Diagnostic Solutions, Inc. — 1 clearance
- Gamma Enterprises, Inc. — 1 clearance
- Panmed, Inc. — 1 clearance

---

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

**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