Sigma CO2 Acid Reagent

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

510(k) Number

K933692 ↗

FDA Product Code

JFL

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 Sigma Chemical Co. →

• What is the Sigma Co2 Acid Reagent used for?

  The Sigma Co2 Acid Reagent is used for the quantitative determination of carbon dioxide in serum or plasma, specifically in clinical chemistry applications.

• Is the Sigma Co2 Acid Reagent supplied sterile?

  The provided data does not specify the sterility of the Sigma Co2 Acid Reagent, but it is intended for use in clinical chemistry applications and is registered with the FDA.

• What system is the Sigma Co2 Acid Reagent used on?

  The Sigma Co2 Acid Reagent is used on the SYNCHRON CX3 System.

• What is the regulatory classification of the Sigma Co2 Acid Reagent?

  The Sigma Co2 Acid Reagent has a product code of JFL and a regulation number of 862.1160, and it is classified as substantially equivalent with a specific K number, K933692.