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510(k) Data Aggregation

    K Number
    K121823
    Device Name
    CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC
    Manufacturer
    WESCOR, INC.
    Date Cleared
    2013-03-27

    (279 days)

    Product Code
    JFS, JJX
    Regulation Number
    862.1170
    Why did this record match?
    Product Code :

    JFS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wescor ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings. The Wescor ChloroChek Chloridometer test system consists of the ChloroChek Chloridometer and the ChloroChek Reagent Set. The ChloroChek Reagent Set (SS-248) is to be used on the ChloroChek. It is used as the titration matrix during the titration process. The 100 mmol/L NaCl/H2O Standard Solution (SS-251), is to be used on the ChloroChek. It is used as a calibration verifier, and quality control solution. The Wescor Sweat Controls (SS-150), levels #1, #2, and #3, are to be used on the ChloroChek. They are used as quality control solutions.
    Device Description
    The CHLOROCHEK™ Chloridometer® test system includes the ChloroChek Chloridometer analyzer and the ChloroChek Reagent Set. The system is for in-vitro diagnostics intended to measure the level of chloride in human sweat. It is a bench top chloride titrator for laboratory determinations of chloride concentrations.
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