Chloride (Mercuric Thiocyanate, Colorimetry)

No FDA recalls on record, checked 22 Oct 2026.

Full name

Chloride

510(k) Number

K850935 ↗

FDA Product Code

CHJ

Device Class

Class II

Regulation

21 CFR Part 862.1170

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

• Calcium

  Class II

  FDA 510(k) K850929 Active Cleared 10 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

• Creatinine

  Class II

  FDA 510(k) K850932 Active Cleared 25 Jun 1985

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• What types of samples can the Chloride Analyzer measure chloride ion concentrations in, and how does it perform this measurement?

  The Chloride Analyzer measures chloride ion concentrations in serum, plasma, and urine samples using a colorimetric method with mercuric thiocyanate. This chemical reaction produces a color change proportional to the chloride levels, allowing precise diagnostic assessment of electrolyte balance and metabolic disorders.

• Is the Chloride Analyzer single-use or reusable, and what storage requirements apply?

  The Chloride Analyzer is supplied as a single-use reagent system, meaning each kit is designed for one-time use only. No special storage conditions are required beyond those outlined in the manufacturer’s instructions, ensuring usability in standard clinical laboratory environments.

• How is the Chloride Analyzer regulated, and what type of review process was used for its FDA clearance?

  The Chloride Analyzer received FDA clearance through a 510(k) submission (K850935) under Traditional review standards, classified as a Class II medical device. It was determined substantially equivalent to a predicate device and falls under the Clinical Chemistry advisory committee (CH). The clearance was granted in 1985.

• What is the primary clinical application of the Chloride Analyzer, and why is chloride level testing important?

  The Chloride Analyzer supports diagnostic assessments for electrolyte balance and metabolic disorders by measuring chloride levels in clinical samples. Chloride is a key electrolyte involved in maintaining acid-base balance, nerve function, and hydration status, making its measurement critical for conditions like renal disease, metabolic alkalosis/acidosis, and hydration disorders.