BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CUE FERTILITY MONITOR

    K Number: K850579 · Decision Mar 22, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    37

    Basic Information

    Device Name
    CUE FERTILITY MONITOR
    K Number
    K850579
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1485
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    ZETEK, INC.
    Date Received
    February 13, 1985
    Decision Date
    March 22, 1985
    Product Code
    NGE
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NGE Test, Luteinizing Hormone (Lh), Over The Counter

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