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

    CYTOTECH CMV IGG EIA

    K Number: K860493 · Decision May 20, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    17
    Applicant Total
    10
    Review Days
    99

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    Basic Information

    Device Name
    CYTOTECH CMV IGG EIA
    K Number
    K860493
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Cytotech, Inc.
    Date Received
    February 10, 1986
    Decision Date
    May 20, 1986
    Product Code
    GQI
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GQI Antiserum, Cf, Cytomegalovirus

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    Other Clearances by Cytotech, Inc.

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    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