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

    TECHNICON DPA-1 IMMUNOGLOBULIN G

    K Number: K883494 · Decision Sep 7, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    157
    Review Days
    22

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    Basic Information

    Device Name
    TECHNICON DPA-1 IMMUNOGLOBULIN G
    K Number
    K883494
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Technicon Instruments Corp.
    Date Received
    August 16, 1988
    Decision Date
    September 7, 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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