BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    E-Z CHECK OZONE TEST STRIPS

    K Number: K132344 · Decision Feb 25, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    211

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    Basic Information

    Device Name
    E-Z CHECK OZONE TEST STRIPS
    K Number
    K132344
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reprocessing Products Corporation (Rpc)
    Date Received
    July 29, 2013
    Decision Date
    February 25, 2014
    Product Code
    MSY
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

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    Other Clearances by Reprocessing Products Corporation (Rpc)

    K Number Device Name
    K222167 E-Z Chek Chlorine Residual Test Strips (K100-0101B)