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510(k) Data Aggregation

    K Number
    K030058
    Device Name
    EARLYDETECT MENOPAUSE TEST FOR FSH
    Manufacturer
    EARLY DETECT, INC.
    Date Cleared
    2003-07-30

    (204 days)

    Product Code
    CGJ
    Regulation Number
    862.1300
    Why did this record match?
    Applicant Name (Manufacturer) :

    EARLY DETECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EarlyDETECT MENOPAUSE TEST is a qualitative rapid membrane immunoassay for the in vitro diagnostic detection of follicle stimulating hormone (FSH) in human urine as a confirmation of hormone changes related to the symptoms associated with the stages of menopause. This device is intended for professional and Over the Counter (OTC) use.
    Device Description
    Rapid Membrane ImmunoAssay
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