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Reagent, Chloride, Coulter

by Coulter Electronics, Inc. 510(k)

Active United States

510(k) K770752

Overview

This device is a reagent for chloride measurement classified under the nomenclature Mercuric Thiocyanate, Colorimetry, Chloride, used in clinical chemistry. It employs colorimetric analysis to determine chloride ion concentrations in biological samples, facilitating diagnostic assessments of electrolyte balance and metabolic disorders.

The reagent is supplied as a single-use chemical for in vitro diagnostic use, intended for integration with automated clinical chemistry analyzers. It adheres to FDA 510(k) clearance (K770752) under regulation 862.1170, with a product code of CHJ. No sterility or MRI safety specifications are noted in the data, and storage conditions are not detailed beyond standard reagent handling. The device was reviewed by the Clinical Chemistry (CH) advisory committee in 1977.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK770752 Date17 Jun 1977ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
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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Questions

  • What is the primary use of this chloride reagent in clinical settings?

    This reagent is designed for measuring chloride ion concentrations in biological samples using colorimetric analysis. It helps clinicians assess electrolyte balance and diagnose metabolic disorders by integrating with automated clinical chemistry analyzers, ensuring precise diagnostic evaluations.

  • Is this reagent intended for single-use or repeated use, and how should it be handled?

    The reagent is explicitly labeled as a single-use chemical for in vitro diagnostic purposes. Since it is not sterile and lacks specific storage instructions beyond standard reagent handling, it should be used once per test cycle and discarded to avoid contamination or degradation of results.

  • What type of analyzers is this reagent compatible with, and how does it function?

    This reagent is intended for integration with automated clinical chemistry analyzers that utilize colorimetric methods. It reacts with chloride ions in the sample via mercuric thiocyanate chemistry, producing a measurable color change proportional to the chloride concentration, enabling accurate quantification.

  • How was the regulatory pathway for this device determined, and what does that mean for its use?

    The device was reviewed under the FDA’s 510(k) clearance process (K770752) and deemed *Substantially Equivalent* to a predicate device, classified under product code CHJ (Clinical Chemistry). This means it follows established safety and performance standards for chloride measurement in clinical chemistry, ensuring its reliability for diagnostic use as intended.