Creatinine Reagent Set

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

510(k) Number

K832439 ↗

FDA Product Code

CGX

Device Class

Class II

Regulation

21 CFR Part 862.1225

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K830957 Active Cleared 18 Apr 1983

• Bicarbonate Reagents Amresco Product #4326020

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  FDA 510(k) K904007 Active Cleared 13 Sep 1990

• Liquilyme Bun Reagent

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• Amresco Subst Concen, Pro #2432, Buf, Nad, 2455, Tri

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• Flow-Pac Albumin Reagent

  Class II

  FDA 510(k) K830536 Active Cleared 24 Mar 1983

• Amresco Flow Pac Chloride Reagent No. 2256 & 2271

  Class II

  FDA 510(k) K860662 Active Cleared 14 Mar 1986

See all devices from Amresco, Inc. →

• What is the Creatinine Reagent Set used for?

  The Creatinine Reagent Set is a clinical chemistry device used for the measurement of creatinine levels in biological samples. It utilizes the alkaline picrate method with colorimetry to determine creatinine concentrations in clinical laboratory settings.

• How is the Creatinine Reagent Set supplied?

  The Creatinine Reagent Set is supplied as a reagent set specifically designed for laboratory use. It is classified as a Class II medical device and is intended for use in clinical chemistry laboratories for measuring creatinine concentrations in biological samples.

• What is the regulatory status of the Creatinine Reagent Set?

  The Creatinine Reagent Set is authorized under FDA 510(k) clearance with the product code CGX. It has been determined to be substantially equivalent to other devices in its class and is classified as a Class II medical device for clinical chemistry laboratory use.

• Is the Creatinine Reagent Set single-use or reusable?

  The Creatinine Reagent Set is supplied as a reagent set for laboratory use. The device is designed for professional laboratory settings where proper handling and storage protocols are maintained to ensure accurate results and product integrity.