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510(k) Data Aggregation

    K Number
    K101750
    Device Name
    RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104
    Manufacturer
    REPROCESSING PRODUCTS CORP.
    Date Cleared
    2011-01-07

    (199 days)

    Product Code
    MNV
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    MNV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprocessing Products Corporation Test Strips are intended for use in the monitoring of pH in Dialysate and Water. The Reprocessing Product Corporation (RPC) pH Test Strips are indicated for determining the pH of acid dialysates, bicarbonate dialysates, or water. These Test Strips are indicated for testing acid/bicarbonate dialysates and water. pH Test Strips are comprised of two different pH ranges: pH = 6.8-8.5 (K100-0117) is for acid/bicarbonate dialysate, bicarbonate concentrate and water pH = 0-14 (K100-0104) is for water used to make up dialysate.
    Device Description
    Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals which change color upon contact with Dialysate or Water respectively. The pad is attached to a plastic strip for handling.
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    K Number
    K031267
    Device Name
    STERICHEK BICARB PH REAGENT STRIPS
    Manufacturer
    ENVIRONMENTAL TEST SYSTEMS, INC.
    Date Cleared
    2003-12-23

    (246 days)

    Product Code
    MNV
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    MNV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriChek® Bicarb pH Reagent Strips provide a quick convenient means of checking the pH of bicarbonate solution used to prepare dialysate and concentrated bicarbonate solutions used in the preparation of dialysate.
    Device Description
    The device is made up of a 0.20 inch square off-white reagent pad that has been chemically treated and affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. The reagent pad is activated by exposing it to the sample. The color of the pad is visually compared to a color chart to determine the pH of the bicarbonate solution.
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