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

    EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT

    K Number: K970467 · Decision Mar 18, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    142
    Applicant Total
    8
    Review Days
    39

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    Basic Information

    Device Name
    EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT
    K Number
    K970467
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1485
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Excel Scientific, Inc.
    Date Received
    February 7, 1997
    Decision Date
    March 18, 1997
    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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