Gilchem Calcium Reagent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K812110 ↗

FDA Product Code

CIC

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Cesium Diluent 7.5M

  Class II

  FDA 510(k) K811886 Active Cleared 23 Jul 1981

• Albumin Reagent

  Class II

  FDA 510(k) K781773 Active Cleared 22 Nov 1978

• Blood Sugar

  Class II

  FDA 510(k) K781783 Active Cleared 4 Dec 1978

• Uric Acid Standard

  Class II

  FDA 510(k) K792046 Active Cleared 30 Oct 1979

• Alt Reagent

  Class I

  FDA 510(k) K800038 Active Cleared 21 Jan 1980

• Cholinesterase Reagent

  Class I

  FDA 510(k) K791725 Active Cleared 17 Oct 1979

See all devices from Gilford Diagnostics →

• What is the Gilchem Calcium Reagent used for?

  The Gilchem Calcium Reagent is used for clinical chemistry testing to measure calcium levels in patient samples, as it contains Cresolphthalein Complexone, Calcium, which reacts with calcium to produce a measurable color change.

• Is the Gilchem Calcium Reagent supplied as a single-use or reusable product?

  The Gilchem Calcium Reagent is supplied as a single-use product, meaning it is intended for one-time use only and should be discarded after each test to prevent contamination and ensure accurate results.

• How should the Gilchem Calcium Reagent be stored?

  The Gilchem Calcium Reagent should be stored according to the manufacturer's instructions, which typically involve keeping it in a cool, dry place away from direct sunlight and extreme temperatures to maintain reagent stability and performance.