Chloride Color & Chloride Sample Diluent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K802163 ↗

FDA Product Code

CHJ

Device Class

Class II

Regulation

21 CFR Part 862.1170

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Chloride Color & Chloride Sample Diluent kit used for?

  This kit is designed for in vitro diagnostic use in clinical laboratories to measure chloride concentration in biological samples. It employs a colorimetric method with mercuric thiocyanate, allowing quantitative assessment of chloride levels through visual or photometric comparison. The results help clinicians evaluate electrolyte balance, which is critical for diagnosing and managing conditions like metabolic disorders or kidney function.

• How is the Chloride Color & Chloride Sample Diluent kit supplied?

  The kit is supplied as a complete single-use system for clinical chemistry applications. It includes all necessary reagents and diluents required to perform chloride measurements in a laboratory setting. Each kit is intended for one-time use to ensure accuracy and prevent cross-contamination, adhering to standard clinical laboratory protocols.

• Is the Chloride Color & Chloride Sample Diluent kit sterile?

  The regulatory data for this device does not specify whether the Chloride Color & Chloride Sample Diluent kit is sterile. For clinical use, it is essential to confirm sterility requirements with the manufacturer or consult local laboratory protocols, as sterility may impact handling and testing procedures.

• Can the Chloride Color & Chloride Sample Diluent kit be reused?

  No, this kit is explicitly intended for single-use applications. Reusing reagents or diluents could compromise test accuracy, introduce contamination, or violate regulatory standards for in vitro diagnostics. Always follow the manufacturer’s instructions to ensure reliable and compliant laboratory practices.

• What regulatory approval does the Chloride Color & Chloride Sample Diluent kit hold?

  The kit received FDA 510(k) clearance under the designation K802163 in 1980, with a determination of substantial equivalence by the Clinical Chemistry (CH) Advisory Committee. It is classified under 21 CFR 862.1170 and is intended for use as an in vitro diagnostic device in clinical chemistry settings.