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

    SS-A(RO) & SS-B(LA) ANTIBODY ASSAY

    K Number: K852033 · Decision Jun 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    109
    Applicant Total
    15
    Review Days
    43

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    Basic Information

    Device Name
    SS-A(RO) & SS-B(LA) ANTIBODY ASSAY
    K Number
    K852033
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Meloy Laboratories, Inc.
    Date Received
    May 9, 1985
    Decision Date
    June 21, 1985
    Product Code
    DHN
    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
    DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

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