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510(k) Data Aggregation

    K Number
    K123805
    Device Name
    E-Z CHEK BLOOD LEAK TEST STRIPS
    Manufacturer
    REPROCESSING PRODUCTS CORP.
    Date Cleared
    2013-03-20

    (99 days)

    Product Code
    FJD
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    REPROCESSING PRODUCTS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprocessing Products Corporation (RPC) E-Z Chek® Blood Leak Test Strips are designed to indicate the presence or absence of blood in dialysate during the hemodialysis procedure. The test strips will measure equal to 0 mg HGB/dL and 0.25 mg HGB/dL in dialysate. The Reprocessing Product Corporation (RPC) E-Z Chek® Blood Leak Test Strips are indicated for detecting the presence or absence of blood in dialysate during hemodialysis treatments.
    Device Description
    Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals which change color upon contact with blood in dialysate. The pad is attached to a plastic strip for handling.
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    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?
    Applicant Name (Manufacturer) :

    REPROCESSING PRODUCTS CORP.

    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
    K090338
    Device Name
    ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE
    Manufacturer
    REPROCESSING PRODUCTS CORP.
    Date Cleared
    2009-05-08

    (87 days)

    Product Code
    MSY
    Regulation Number
    876.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    REPROCESSING PRODUCTS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprocessing Product Corporation (RPC) Total Chlorine Test Strips are indicated for detection of Free Chlorine and Total Chlorine in water. These Test Strips are indicated for testing water used to prepare dialysate (Free Chlorine and Chloramines) and for testing rinse water following dialysis equipment disinfection (Free Chlorine).
    Device Description
    Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals which change color upon contact with Free Chlorine or Chloramines. The pad is attached to a plastic strip for handling. The color change is interpreted by the use of color blocks on two separate (ranges) color charts. Gradations for the Ultra-Low Total Chlorine (K100-0118) color chart include 0 ppm, 0.01 ppm, 0.02 ppm, 0.05ppm, 0.1ppm, 0.15ppm, 0.2 ppm. Gradations for the E-Z Chek® Sensitive Total Chlorine (K100-0106) color chart include 0 ppm, 0.1 ppm, 0.5 ppm and 3.0 ppm.
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    K Number
    K974426
    Device Name
    POTENCY TEST STRIPS, INDICATOR TEST STRIPS
    Manufacturer
    REPROCESSING PRODUCTS CORP.
    Date Cleared
    1999-02-10

    (471 days)

    Product Code
    LIF
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    REPROCESSING PRODUCTS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Micro-X Potency Test Strips are intended for use as a semi-quantitative test of the presence of peracetic acid in dialyzers after reprocessing. This device may be used with all peroxyacetic/peracetic acid germicides used in the reprocessing of dialyzers as part of an established quality assurance program.
    Device Description
    Micro X Potency Test Strips are approximately 0.25" x 2.0" packaged 100strips /container. The strips are labeled for use in Reprocessing Hemodialyzers. Micro Xen Potency Test Strips are impregnated with an indicator solution which is activated by the presence of peracetic acid. The reaction results in a color change of the indicator which provides visual confirmation of the presence of peracetic acid.
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    K Number
    K974064
    Device Name
    MICRO X RESIDUAL TEST STRIPS
    Manufacturer
    REPROCESSING PRODUCTS CORP.
    Date Cleared
    1998-12-07

    (406 days)

    Product Code
    MSY
    Regulation Number
    876.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    REPROCESSING PRODUCTS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Micro-X Residual Test Strips are intended for use as a semi-quantitative test of the residual presence of peracetic acid in dialyzers after reprocessing. This device may be used with all peroxyacetic/peracetic acid germicides used in the reprocessing of dialyzers, sanitation of water treatment systems and dialysis machine disinfection as part of an established quality assurance program.
    Device Description
    Micro Xtm Residual Test Strips are approximately 0.25" x 4.75" packaged 100strips /container. The strips are labeled for use in Reprocessing Hemodialyzers. Micro X " Test Strips have a test pad, which is impregnated with peroxidase, which liberates oxygen from peracetic acid upon contact with the solution. The oxygen reacts with the chromophore, color indicator, which is also present on the test pad, resulting in a color change. The color change is compared to the color scale on the container and the result is read directly in mg/L.
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