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

    CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT

    K Number: K871801 · Decision Jun 9, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    109
    Applicant Total
    10
    Review Days
    32

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    Basic Information

    Device Name
    CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT
    K Number
    K871801
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Cytotech, Inc.
    Date Received
    May 8, 1987
    Decision Date
    June 9, 1987
    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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    K872426 CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY
    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