Sclavo Chloride Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K843740 ↗

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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See all devices from Sclavo, Inc. →

• What types of biological samples can the Sclavo Chloride Test measure chloride levels in, and how does it work?

  The Sclavo Chloride Test is designed to quantitatively measure chloride levels in plasma, serum, sweat, and urine. It uses a colorimetric method with mercuric thiocyanate to detect chloride concentrations, helping clinicians diagnose electrolyte and metabolic disorders by providing objective measurements from these biological samples.

• Is the Sclavo Chloride Test intended for single-use or repeated use, and how is it supplied?

  The Sclavo Chloride Test is supplied as a single-use reagent system for in vitro diagnostic use in clinical chemistry laboratories. This means each kit is intended for one-time use per test, ensuring consistency and reliability in chloride measurements without risk of cross-contamination.

• What regulatory pathway was followed for FDA clearance of the Sclavo Chloride Test, and what classification does it hold?

  The Sclavo Chloride Test received FDA clearance under the Traditional 510(k) pathway and is classified as a Class II device (Product Code: CHJ). This classification reflects its role in clinical chemistry, where it aids in diagnosing conditions related to electrolyte and metabolic balance.

• Are there specific storage instructions provided for the Sclavo Chloride Test, or is it considered sterile?

  The regulatory data for the Sclavo Chloride Test does not specify sterility requirements or detailed storage conditions. Laboratories should follow general best practices for reagent storage, such as protecting from light, moisture, and extreme temperatures, to maintain accuracy and reliability of results.