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

    ALPHA-2 MACROGLOBULIN TEST RID KIT

    K Number: K914389 · Decision Dec 20, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    115
    Review Days
    80

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    Basic Information

    Device Name
    ALPHA-2 MACROGLOBULIN TEST RID KIT
    K Number
    K914389
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5620
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Binding Site, Ltd.
    Date Received
    October 1, 1991
    Decision Date
    December 20, 1991
    Product Code
    DEB
    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
    DEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control

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