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510(k) Data Aggregation

    K Number
    K032939
    Device Name
    EPT CERTAINTY PREGNANCY TEST
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    2003-10-20

    (28 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EPT CERTAINTY PREGNANCY TEST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    EPT Certainty™ Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mIU/ml hCG in urine, and can be used from the first day of the missed period.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a pregnancy test. It does not contain information about the acceptance criteria, device performance, or details of a study that proves the device meets specific criteria. It only states the device's indications for use and sensitivity. Therefore, I cannot extract the requested information from the provided text.

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