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

    SURE CHECK OVULATION PREDICTOR

    K Number: K010244 · Decision May 2, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    142
    Applicant Total
    6
    Review Days
    97

    Basic Information

    Device Name
    SURE CHECK OVULATION PREDICTOR
    K Number
    K010244
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1485
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chembio Diagnostic Systems, Inc.
    Date Received
    January 25, 2001
    Decision Date
    May 2, 2001
    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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