Calcium (Arsenazo III) for Manual/Auto Application

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K894476 ↗

FDA Product Code

CJY

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Alanine Aminotransferase (Alt)/(Gpt)

  Class I

  FDA 510(k) K870086 Active Cleared 6 Mar 1987

• Aspartate Aminotransferase (Ast)/(Got)

  Class II

  FDA 510(k) K870077 Active Cleared 6 Mar 1987

• Uibc for Discreet Random Access Analyzer

  Class I

  FDA 510(k) K932871 Active Cleared 8 Sep 1993

• Direct Bilirubin for Manual or Automated Appli.

  Class II

  FDA 510(k) K892905 Active Cleared 19 Jun 1989

• Magnesium

  Class I

  FDA 510(k) K903341 Active Cleared 22 Aug 1990

• Uric Acid for Manual/Automated Applications

  Class I

  FDA 510(k) K895821 Active Cleared 5 Dec 1989

See all devices from Catachem, Inc. →

• What is the Calcium (Arsenazo III) reagent used for?

  The Calcium (Arsenazo III) reagent is designed for the quantitative determination of calcium levels in biological specimens in laboratory settings. It can be used for both manual and automated applications in clinical chemistry testing.

• Is the Calcium (Arsenazo III) reagent single-use or reusable?

  This reagent is supplied as a single-use product and is not intended for reuse. Each container should be used for one testing procedure and then properly disposed of according to laboratory protocols.

• What regulatory approvals does the Calcium (Arsenazo III) reagent have?

  The Calcium (Arsenazo III) reagent is authorized under FDA 510K clearance with product code CJY. It is classified as a Class II device for clinical chemistry applications and has been determined to be substantially equivalent to predicate devices.

• Is the Calcium (Arsenazo III) reagent compatible with MRI procedures?

  No, the Calcium (Arsenazo III) reagent is not MRI compatible. It should only be used in standard laboratory settings for clinical chemistry applications and should not be used in MRI environments.