BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ANTI SERA TO HUMAN OROSCOMUCOID

    K Number: K823765 · Decision Dec 30, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    4
    Applicant Total
    40
    Review Days
    16

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    Basic Information

    Device Name
    ANTI SERA TO HUMAN OROSCOMUCOID
    K Number
    K823765
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5420
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Kent Laboratories, Inc.
    Date Received
    December 14, 1982
    Decision Date
    December 30, 1982
    Product Code
    DEX
    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
    DEX Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control

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