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

    PEAK OVULATION PREDICTOR

    K Number: K863121 · Decision Oct 14, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    61

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    Basic Information

    Device Name
    PEAK OVULATION PREDICTOR
    K Number
    K863121
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1485
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Micron Technology, Inc.
    Date Received
    August 14, 1986
    Decision Date
    October 14, 1986
    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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