BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G

    K Number: K884074 · Decision Oct 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    28
    Review Days
    30

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    Basic Information

    Device Name
    IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G
    K Number
    K884074
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Orion Diagnostica, Inc.
    Date Received
    September 27, 1988
    Decision Date
    October 27, 1988
    Product Code
    DAH
    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
    DAH Gamma Globulin, Antigen, Antiserum, Control

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