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

    E-Z CHEK BLOOD LEAK TEST STRIPS

    K Number: K123805 · Decision Mar 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    6
    Review Days
    99

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    Basic Information

    Device Name
    E-Z CHEK BLOOD LEAK TEST STRIPS
    K Number
    K123805
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reprocessing Products Corp
    Date Received
    December 11, 2012
    Decision Date
    March 20, 2013
    Product Code
    FJD
    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
    FJD Detector, Leak, Blood

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