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

    ACCESS R-CLONE ANA PROFILE ASSAY

    K Number: K885048 · Decision Jan 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    15
    Review Days
    48

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    Basic Information

    Device Name
    ACCESS R-CLONE ANA PROFILE ASSAY
    K Number
    K885048
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5820
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Lipogen, Inc.
    Date Received
    December 7, 1988
    Decision Date
    January 24, 1989
    Product Code
    DHC
    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
    DHC System, Test, Systemic Lupus Erythematosus

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