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510(k) Data Aggregation

    K Number
    K253863

    Validate with FDA (Live)

    Device Name
    GUARDIAN™ Quick Dip Residual Chlorine (5212)
    Manufacturer
    Serim Research
    Date Cleared
    2026-03-17

    (104 days)

    Product Code
    FKJ
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    K901734
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    GUARDIAN™ Quick Dip Residual Chlorine (5212) Test Strips provide a convenient means for indicating the concentration of chlorine bleach (sodium hypochlorite) remaining in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment.

    Device Description

    The device is a semiquantitative, single use, reagent test strip made up of a 0.20-inch square reagent pad that has been chemically treated to detect residual free chlorine in water. The pad is affixed to one end of a 3.25 inch by 0.20-inch white opaque polystyrene strip.

    AI/ML Overview

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