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

    DETERM. SIZE 72 RADIAL-HUMAN IGD

    K Number: K831956 · Decision Jul 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    7
    Applicant Total
    40
    Review Days
    31

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    Basic Information

    Device Name
    DETERM. SIZE 72 RADIAL-HUMAN IGD
    K Number
    K831956
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Kent Laboratories, Inc.
    Date Received
    June 17, 1983
    Decision Date
    July 18, 1983
    Product Code
    CZJ
    Advisory Committee
    Immunology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CZJ Igd, Antigen, Antiserum, Control

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