CO2

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K981231 ↗

FDA Product Code

KHS

Device Class

Class II

Regulation

21 CFR Part 862.1160

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Abbott Mfg., Inc. →

• What is the CO2 reagent used for?

  The CO2 is an enzymatic carbon dioxide reagent designed for use with the Alinity c Analyzer in clinical chemistry laboratory workflows for diagnostic purposes.

• How is the CO2 reagent supplied?

  The CO2 reagent is supplied as a general chemistry reagent that provides 3,000 tests per supply, manufactured by Abbott Mfg., Inc.

• What is the regulatory status of the CO2 reagent?

  The CO2 reagent has FDA 510(k) clearance with number K981231, received on April 3, 1998, and cleared on May 12, 1998, through the Traditional pathway after a 39-day FDA review.

• What class of device is the CO2 reagent?

  The CO2 is a Class 2 Chemistry device with product code KHS, designed for use with the Alinity c Analyzer for diagnostic purposes in clinical chemistry laboratories.