Glucose Trinder Reagent

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

510(k) Number

K850364 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K896092 Active Cleared 9 Nov 1989

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• Dulbecco's Modified Eagle's Med. (Dme) W/Glucose a

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• Dulbecco's Modified Eagle #D5523-

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• Ast Reagent (Procedure Number 158)

  Class II

  FDA 510(k) K892844 Active Cleared 20 Jun 1989

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See all devices from Sigma Chemical Co. →

• What is the primary use of the Glucose Trinder Reagent?

  This device is intended for the quantitative determination of glucose in biological samples, serving as a clinical chemistry reagent for laboratory analysis.

• What type of device is the Glucose Trinder Reagent?

  It is classified as a glucose oxidase reagent, which is a specific type of clinical chemistry device used to measure glucose concentrations.

• Is this device regulated by the FDA?

  Yes, the Glucose Trinder Reagent received FDA 510(k) clearance on March 5, 1985, under regulation number 862.1345 and product code CGA.