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

    WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM

    K Number: K981750 · Decision Jul 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    5
    Review Days
    65

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    Basic Information

    Device Name
    WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM
    K Number
    K981750
    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
    May 18, 1998
    Decision Date
    July 22, 1998
    Product Code
    MOB
    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
    MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

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    Other Clearances by Wieslab AB

    K Number Device Name
    K981748 WIELISA ANCA SCREENING KIT TEST SYSTEM
    K974169 WIELISA ANTI-GBM TEST SYSTEM
    K974166 WIELISA MPO ANCA TEST SYSTEM
    K974167 WIELISA PR-3 ANCA TEST SYSTEM