Cholorde Reagent

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K791690 ↗

FDA Product Code

JFS

Device Class

Class II

Regulation

21 CFR Part 862.1170

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Astra-T Calcium Reagent

  Class II

  FDA 510(k) K820090 Active Cleared 28 Jan 1982

• Cholar Produ&T #17010

  Class I

  FDA 510(k) K771731 Active Cleared 25 Oct 1977

• Direct Bilirubin Reagent

  Class II

  FDA 510(k) K841572 Active Cleared 16 May 1984

• Hilar

  Class II

  FDA 510(k) K782094 Active Cleared 17 Jan 1979

• Ast Reagent Cartridge

  Class II

  FDA 510(k) K861283 Active Cleared 28 Apr 1986

• Electrolyte Gel

  Class II

  FDA 510(k) K813370 Active Cleared 22 Dec 1981

See all devices from Hi Chem, Inc. →

• What is the Cholorde Reagent used for in a clinical setting?

  The Cholorde Reagent is designed for measuring chloride ion concentrations in serum, plasma, or other biological samples. It is used in automated or manual laboratory systems to help diagnose electrolyte imbalances and metabolic disorders by providing accurate chloride level readings.

• Is the Cholorde Reagent intended for single-use or repeated use?

  The Cholorde Reagent is explicitly supplied as a single-use chemical solution for in vitro diagnostic testing. It is not intended for reuse, as it is formulated for one-time use in clinical chemistry applications.

• How should the Cholorde Reagent be stored, and are there any special handling requirements?

  Storage follows standard laboratory protocols for chemical reagents, as no specific sterility or specialized handling instructions (e.g., MRI safety) are noted. It should be kept in a controlled environment per typical reagent guidelines, ensuring proper labeling and access restrictions.

• What regulatory pathway was used for the FDA clearance of the Cholorde Reagent?

  The Cholorde Reagent was cleared through the Traditional 510(k) pathway in 1979, with a decision of Substantially Equivalent (SESE). It is classified as a Class II device under FDA regulations (product code JFS) and falls under the Clinical Chemistry advisory committee.

• Does the Cholorde Reagent require any special compatibility considerations when used in automated systems?

  The Cholorde Reagent is designed for use in automated or manual laboratory systems for chloride testing. While no explicit compatibility details are provided beyond its role as a coulometric reagent, it should adhere to the manufacturer’s instructions for integration with specific lab equipment to ensure accurate results.