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

    DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368

    K Number: K032692 · Decision Jan 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    52
    Applicant Total
    2
    Review Days
    142

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    Basic Information

    Device Name
    DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368
    K Number
    K032692
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5630
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dako A/S
    Date Received
    September 2, 2003
    Decision Date
    January 22, 2004
    Product Code
    JZG
    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
    JZG System, Test, Beta-2-Microglobulin Immunological

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