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

    ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS

    K Number: K873249 · Decision Sep 22, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    49
    Applicant Total
    10
    Review Days
    36

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    Basic Information

    Device Name
    ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS
    K Number
    K873249
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Cytotech, Inc.
    Date Received
    August 17, 1987
    Decision Date
    September 22, 1987
    Product Code
    LKJ
    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
    LKJ Antinuclear Antibody, Antigen, Control

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    Other Clearances by Cytotech, Inc.

    K Number Device Name
    K882829 CIRCULATING IMMUNE COMPLEXES CONTROLS
    K874379 CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY
    K872426 CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY
    K871801 CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT
    K864315 CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY
    K862838 CYTOTECH HSV IGG ENZYME IMMUNOASSAY
    K863363 CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY
    K862649 CYTOTECH CIC ENZYME IMMUNOASSAY
    K860493 CYTOTECH CMV IGG EIA