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

    NUCLEAR ANTIGENS

    K Number: K810592 · Decision Oct 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    179
    Applicant Total
    1
    Review Days
    232

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    Basic Information

    Device Name
    NUCLEAR ANTIGENS
    K Number
    K810592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Alpha Antigens, Inc.
    Date Received
    March 5, 1981
    Decision Date
    October 23, 1981
    Product Code
    LLL
    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
    LLL Extractable Antinuclear Antibody, Antigen And Control

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