Calcium, Azo Dye Reagent

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

510(k) Number

K040972 ↗

FDA Product Code

CJY

FDA applicant

Genchem, Inc.

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Genchem Electrolyte Buffer

  Class II

  FDA 510(k) K040977 Active Cleared 27 Dec 2004

• Genchem CO2 Acid Reagent

  Class II

  FDA 510(k) K040975 Active Cleared 27 Dec 2004

• Calibrator 1, 2, and 3 Models: Gen-CAL1, Gen-CAL2, and Gen-CAL3

  Class II

  FDA 510(k) K090283 Active Cleared 5 Jun 2009

• Genchem Ise Electrolyte Reference

  Class II

  FDA 510(k) K040971 Active Cleared 22 Dec 2004

• Bun Reagent

  Class II

  FDA 510(k) K040973 Active Cleared 27 Dec 2004

• Glucose Oxidase, Glucose

  Class II

  FDA 510(k) K040974 Active Cleared 27 Dec 2004

See all devices from Genchem Inc →

• What is the Calcium Azo Dye Reagent used for?

  The Calcium Azo Dye Reagent is intended for the qualitative and/or quantitative detection of calcium (Ca2+) in clinical specimens using a spectrophotometry method. It is part of a test system for calcium measurement in clinical chemistry laboratories.

• How is the Calcium Azo Dye Reagent supplied and for what setting is it intended?

  The reagent is supplied as a collection of reagents and associated materials for use in clinical chemistry laboratories. It is intended for in vitro diagnostic use as part of a test system to measure calcium levels in patient specimens.

• Is the Calcium Azo Dye Reagent sterile or single-use?

  The device data does not specify whether the reagent is sterile or single-use. It is described as a collection of reagents and associated materials intended for use in clinical chemistry laboratories, but no details about sterility, packaging, or reuse are provided in the available information.

• What regulatory pathway was used for the Calcium Azo Dye Reagent?

  The Calcium Azo Dye Reagent received FDA 510(k) clearance under submission number K040972, with a decision date of December 27, 2004. It was found substantially equivalent to a predicate device and cleared through the traditional 510(k) pathway.