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

    BETA-2 MICROGLOBULIN EIA

    K Number: K890694 · Decision Mar 16, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    52
    Applicant Total
    5
    Review Days
    34

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    Basic Information

    Device Name
    BETA-2 MICROGLOBULIN EIA
    K Number
    K890694
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5630
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Serex, Inc.
    Date Received
    February 10, 1989
    Decision Date
    March 16, 1989
    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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    Other Clearances by Serex, Inc.

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