Hichem Calcium Reagent for the Synchron CX3 Prod. No. 88808

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

510(k) Number

K941764 ↗

FDA Product Code

CJY

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Astra-T Calcium Reagent

  Class II

  FDA 510(k) K820090 Active Cleared 28 Jan 1982

• Cholar Produ&T #17010

  Class I

  FDA 510(k) K771731 Active Cleared 25 Oct 1977

• Direct Bilirubin Reagent

  Class II

  FDA 510(k) K841572 Active Cleared 16 May 1984

• Cholorde Reagent

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  FDA 510(k) K791690 Active Cleared 17 Sep 1979

• Hilar

  Class II

  FDA 510(k) K782094 Active Cleared 17 Jan 1979

• Ast Reagent Cartridge

  Class II

  FDA 510(k) K861283 Active Cleared 28 Apr 1986

See all devices from Hi Chem, Inc. →

• What is the HICHEM Calcium Reagent used for?

  The HICHEM Calcium Reagent is intended for use in clinical chemistry testing on the Synchron CX3 analyzer to measure calcium levels in patient samples. It is classified as an Azo Dye, Calcium reagent under product code CJY and is designed specifically for this analytical purpose in laboratory settings.

• How is the HICHEM Calcium Reagent supplied and intended for use?

  The reagent is supplied as an in vitro diagnostic product for use in laboratory settings. It is intended for professional use in clinical laboratories and is designed to be used with the Synchron CX3 analyzer for calcium testing.

• What regulatory clearance does the HICHEM Calcium Reagent have?

  The device received FDA 510(k) clearance (K941764) on May 13, 1994, and is regulated as a Class II device under regulation number 862.1145 with special controls. This clearance indicates it was found substantially equivalent to a legally marketed predicate device.