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

    STERICHEK BLOOD LEAK REAGENT STRIPS

    K Number: K042322 · Decision Dec 7, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    4
    Review Days
    103

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    Basic Information

    Device Name
    STERICHEK BLOOD LEAK REAGENT STRIPS
    K Number
    K042322
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hach Company
    Date Received
    August 26, 2004
    Decision Date
    December 7, 2004
    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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