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

    ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY

    K Number: K962926 · Decision Oct 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    93
    Applicant Total
    27
    Review Days
    73

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    Basic Information

    Device Name
    ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY
    K Number
    K962926
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Laboratory Products Co., Ltd.
    Date Received
    July 29, 1996
    Decision Date
    October 10, 1996
    Product Code
    MID
    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
    MID System, Test, Anticardiolipin Immunological

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