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510(k) Data Aggregation

    K Number
    K251800

    Validate with FDA (Live)

    Device Name
    Healgen® URS Test Strips
    Manufacturer
    Healgen Scientific, LLC
    Date Cleared
    2025-12-23

    (194 days)

    Product Code
    LJX
    Regulation Number
    864.7675
    Type
    Traditional
    Panel
    Clinical Chemistry
    Age Range
    All
    Reference & Predicate Devices
    K111999,K231045
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K111999

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

    The Healgen® URS Test Strips are for the qualitative detection of leukocytes (white blood cells) and nitrite in urine as an aid in the screening of a urinary tract infection (UTI). It is intended for over-the-counter home use only.

    Device Description

    The Healgen® URS Test Strips are in vitro diagnostic test devices for the qualitative detection of leukocytes and nitrites in urine. The device is composed of two color pads aligned on a strip. One pad is employed for testing leukocytes and the other for nitrites by visually reading the color change of the applicable pad and comparing with the corresponding blocks on a color chart.

    AI/ML Overview

    N/A

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