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510(k) Data Aggregation

    K Number
    K060019
    Device Name
    ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)
    Manufacturer
    ARTRON LABORATORIES, INC.
    Date Cleared
    2006-02-17

    (44 days)

    Product Code
    LCXJHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARTRON LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Artron One-Step hCG Urinary Pregnancy Test Device is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine to help in the early determination of pregnancy. The device is designed for over-the-counter use as well as professional use. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.
    Device Description
    Not Found
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