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

    ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT

    K Number: K983696 · Decision Feb 5, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    93
    Applicant Total
    115
    Review Days
    107

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    Basic Information

    Device Name
    ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT
    K Number
    K983696
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Binding Site, Ltd.
    Date Received
    October 21, 1998
    Decision Date
    February 5, 1999
    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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