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510(k) Data Aggregation

    K Number
    K040341
    Device Name
    CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    2004-03-08

    (25 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 :

    CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST

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

    Clearblue Easy Earliest Results Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a pregnancy test, not a study describing acceptance criteria and performance of a device with AI. Therefore, I cannot extract the requested information.

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