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510(k) Data Aggregation

    K Number
    K222167
    Device Name
    E-Z Chek Chlorine Residual Test Strips (K100-0101B)
    Manufacturer
    Reprocessing Products Corporation (RPC)
    Date Cleared
    2022-10-18

    (89 days)

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

    Reprocessing Products Corporation (RPC)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    E-Z Chek® Residual Chlorine Test Strips (K100-0101B) provide accurate and convenient means of measuring the concentration of free chlorine remaining in water when rinsing out equipment following disinfection. A rapid screening qualitative method will detect levels above 0.5ppm (mg/L) while the 30 second semi-quantitative method allows interpolation of concentration between 0ppm and 5ppm. The qualitative method can be used to determine that chlorine has been adequately rinsed from the equipment. The semi-quantitative method may be useful when corrective measures are undertaken on equipment retaining higher levels of chlorine for extended periods and for testing any containers disinfected with free chlorine (bleach).
    Device Description
    Reprocessing Products Corporation (RPC) E-Z Chek® Residual Chlorine Test Strips (K100-0101B) is semi-quantitative or qualitative, reagent test strip comprised of a pad impregnated with chemicals, which change color upon contact with free chlorine and combined chlorine (monochloramines). The pad is attached to a plastic strip for handling.
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    K Number
    K132344
    Device Name
    E-Z CHECK OZONE TEST STRIPS
    Manufacturer
    REPROCESSING PRODUCTS CORPORATION (RPC)
    Date Cleared
    2014-02-25

    (211 days)

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

    REPROCESSING PRODUCTS CORPORATION (RPC)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprocessing Products Corporation (RPC) E-Z Chek® Ozone Test Strips (K100-0111) are designed to indicate the presence of ozone in water used in hemodialysis. The test strips will measure equal to 0.0, 0.05, 0.1, 0.2, 0.3, 0.4, and >0.5 mg/L.
    Device Description
    Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals, which change color upon contact with Ozone. The pad is attached to a plastic strip for handling.
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