Chloride

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K883386 ↗

FDA Product Code

CHJ

Device Class

Class II

Regulation

21 CFR Part 862.1170

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Creatinine

  Class II

  FDA 510(k) K880629 Active Cleared 23 Mar 1988

• Uric Acid

  Class I

  FDA 510(k) K863924 Active Cleared 24 Nov 1986

• Cholesterol

  Class I

  FDA 510(k) K863927 Active Cleared 24 Nov 1986

• Hemoglobin

  Class II

  FDA 510(k) K883683 Active Cleared 6 Oct 1988

• Triglycerides

  Class I

  FDA 510(k) K863923 Active Cleared 24 Nov 1986

• Bilirubin (Direct)

  Class II

  FDA 510(k) K881172 Active Cleared 7 Jun 1988

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• What is the CHLORIDE device used for?

  The CHLORIDE device is used for the quantitative determination of chloride ions in biological specimens within clinical chemistry laboratories, employing a mercuric thiocyanate colorimetry method.

• How is the CHLORIDE device supplied and intended for use?

  The device is supplied as a reagent system for in vitro diagnostic use and is intended for use in laboratory settings to measure chloride levels in biological samples.

• What regulatory pathway was used for the CHLORIDE device?

  The CHLORIDE device was cleared through the FDA 510(k) process under product code CHJ and regulation number 862.1170, classified as substantially equivalent to a legally marketed device.