Skip to content

Carbon Dioxide Reagents

by Gamma Enterprises, Inc.

510(k) K780506

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK780506 Date3 May 1978ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KMS
Device Class
Class II
Regulation
21 CFR Part 862.1160
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Carbon Dioxide Reagents are chemical preparations used in clinical chemistry to measure carbon dioxide and bicarbonate levels in plasma, serum, and whole blood. They function as part of a colorimetric test system, typically reacting with the sample to produce a measurable color change proportional to the analyte concentration.

These reagents are supplied by Gamma Enterprises, Inc. and are intended for in vitro diagnostic use in laboratory settings. The device is regulated under FDA product code KMS and was cleared through the traditional 510(k) process under k-number K780506, with a decision date of May 3, 1978.

Other devices from Gamma Enterprises, Inc.

  • Creatine Phosphokinase (CPK)

    Class II

  • Potassium

    Class II

  • Calcium

    Class II

  • Chloride

    Class II

  • Sodium

    Class II

  • Gamma Smac Reagents

    Class II

See all devices from Gamma Enterprises, Inc. →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are Carbon Dioxide Reagents used for?

    They are used to measure carbon dioxide and bicarbonate levels in plasma, serum, and whole blood as part of a colorimetric test system.

  • How are Carbon Dioxide Reagents supplied?

    They are supplied by Gamma Enterprises, Inc. for in vitro diagnostic use in laboratory settings.

  • Are Carbon Dioxide Reagents single-use or reusable?

    The device data does not specify if the reagents are single-use or reusable, but they are intended for in vitro diagnostic use.

  • What is the regulatory classification of Carbon Dioxide Reagents?

    The device is regulated under FDA product code KMS and was cleared through the traditional 510(k) process.