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

    SS-A/SS-B AUTOANTIBODY TEST SYSTEM

    K Number: K860644 · Decision Mar 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    179
    Applicant Total
    36
    Review Days
    36

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    Basic Information

    Device Name
    SS-A/SS-B AUTOANTIBODY TEST SYSTEM
    K Number
    K860644
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Immuno Concepts, Inc.
    Date Received
    February 20, 1986
    Decision Date
    March 28, 1986
    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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    Other Clearances by Immuno Concepts, Inc.

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