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

    WIELISA ANTI-GBM TEST SYSTEM

    K Number: K974169 · Decision Feb 17, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    5
    Review Days
    104

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    Basic Information

    Device Name
    WIELISA ANTI-GBM TEST SYSTEM
    K Number
    K974169
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wieslab AB
    Date Received
    November 5, 1997
    Decision Date
    February 17, 1998
    Product Code
    DBL
    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
    DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

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    Other Clearances by Wieslab AB

    K Number Device Name
    K981748 WIELISA ANCA SCREENING KIT TEST SYSTEM
    K981750 WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM
    K974166 WIELISA MPO ANCA TEST SYSTEM
    K974167 WIELISA PR-3 ANCA TEST SYSTEM