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

    ORGENTEC ANTI-MPO (P-ANCA) ELISA

    K Number: K974701 · Decision Feb 17, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    27
    Review Days
    71

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    Basic Information

    Device Name
    ORGENTEC ANTI-MPO (P-ANCA) ELISA
    K Number
    K974701
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Laboratory Products Co., Ltd.
    Date Received
    December 8, 1997
    Decision Date
    February 17, 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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