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

    KALLESTAD'S ENDOPLATE FACTOR B TEST

    K Number: K811740 · Decision Jul 16, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    92
    Review Days
    27

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    Basic Information

    Device Name
    KALLESTAD'S ENDOPLATE FACTOR B TEST
    K Number
    K811740
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5320
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Kallestad Laboratories, Inc.
    Date Received
    June 19, 1981
    Decision Date
    July 16, 1981
    Product Code
    JZH
    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
    JZH Factor B, Antigen, Antiserum, Control

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