CALCIUM

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K850929 ↗

FDA Product Code

CIC

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Rapid As Latex

  Class I

  FDA 510(k) K862530 Active Cleared 21 Apr 1987

• Total Proteins

  Class II

  FDA 510(k) K850936 Active Cleared 25 Jun 1985

• Phosphorus

  Class I

  FDA 510(k) K850934 Active Cleared 25 Jun 1985

• Albumin

  Class II

  FDA 510(k) K850931 Active Cleared 26 Jun 1985

• Chloride (Mercuric Thiocyanate, Colorimetry)

  Class II

  FDA 510(k) K850935 Active Cleared 10 Jun 1985

• Creatinine

  Class II

  FDA 510(k) K850932 Active Cleared 25 Jun 1985

See all devices from Dilab, Inc. →

• What is the CALCIUM device used for?

  CALCIUM is a clinical chemistry device used for the quantitative determination of calcium levels in human specimens. It operates based on the Cresolphthalein Complexone method to measure calcium concentrations accurately in laboratory settings.

• Is the CALCIUM device single-use or reusable?

  The CALCIUM device is supplied as a single-use product and is intended for laboratory use only. It should not be reused or repurposed after initial use to ensure accurate test results and maintain safety standards.

• What are the storage requirements for the CALCIUM device?

  The CALCIUM device requires storage under conditions specified by the manufacturer. As it is MRI safe, proper storage conditions should be followed to maintain the device's integrity and functionality for accurate calcium level measurements.

• What is the regulatory classification of the CALCIUM device?

  The CALCIUM device has FDA 510K clearance with product code CIC and is classified as Class II. This indicates it has been determined to be substantially equivalent to existing devices for the same indications, following the traditional clearance process.