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510(k) Data Aggregation

    K Number
    K053452
    Device Name
    PURE-AID PREGNANCY TEST
    Manufacturer
    BIO FOCUS CO., LT.
    Date Cleared
    2006-05-25

    (164 days)

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

    BIO FOCUS CO., LT.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Pure-Aid Pregnancy Test is intended for the qualitative determination of Human Chorionic Gonadotropin (hCG) in Human urine. The test is for Over-The-Counter use. The test is for the early detection of pregnancy.
    Device Description
    Not Found
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