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

    DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO

    K Number: K840404 · Decision Mar 9, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    17
    Applicant Total
    8
    Review Days
    38

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    Basic Information

    Device Name
    DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO
    K Number
    K840404
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5460
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Tago, Inc.
    Date Received
    January 31, 1984
    Decision Date
    March 9, 1984
    Product Code
    DAD
    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
    DAD Haptoglobin, Antigen, Antiserum, Control

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