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

    ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST

    K Number: K852840 · Decision Aug 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    111
    Applicant Total
    5
    Review Days
    27

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    Basic Information

    Device Name
    ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST
    K Number
    K852840
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Modern Diagnostics, Inc.
    Date Received
    July 5, 1985
    Decision Date
    August 1, 1985
    Product Code
    LJM
    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
    LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

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