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

    RADIAL IMMUNODIFFUSION PLATES

    K Number: K830911 · Decision Jun 10, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    47
    Applicant Total
    6
    Review Days
    81

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    Basic Information

    Device Name
    RADIAL IMMUNODIFFUSION PLATES
    K Number
    K830911
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5880
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Biocell Laboratories, Inc.
    Date Received
    March 21, 1983
    Decision Date
    June 10, 1983
    Product Code
    DDG
    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
    DDG Transferrin, Antigen, Antiserum, Control

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