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

    CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM

    K Number: K091845 · Decision Jun 7, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    93
    Applicant Total
    22
    Review Days
    350

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    Basic Information

    Device Name
    CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
    K Number
    K091845
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phadia US, Inc.
    Date Received
    June 22, 2009
    Decision Date
    June 7, 2010
    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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