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

    OVUTIME OVULATION PREDICTOR TEST

    K Number: K853142 · Decision Dec 17, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    142
    Applicant Total
    6
    Review Days
    141

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    Basic Information

    Device Name
    OVUTIME OVULATION PREDICTOR TEST
    K Number
    K853142
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1485
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Advanced Care Products
    Date Received
    July 29, 1985
    Decision Date
    December 17, 1985
    Product Code
    CEP
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CEP Radioimmunoassay, Luteinizing Hormone

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