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

    BIOPLEX VASCULITIS KIT

    K Number: K072358 · Decision Oct 31, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    5
    Applicant Total
    46
    Review Days
    70

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    Basic Information

    Device Name
    BIOPLEX VASCULITIS KIT
    K Number
    K072358
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Rad Laboratories
    Date Received
    August 22, 2007
    Decision Date
    October 31, 2007
    Product Code
    MVJ
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

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