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510(k) Data Aggregation

    K Number
    K022755
    Device Name
    LIFEGUARD
    Manufacturer
    Date Cleared
    2002-09-24

    (35 days)

    Product Code
    Regulation Number
    864.6550
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTEK LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LifeGuard™ is a guaiac-based test for the qualitative detection of occult blood in stool, which may indicate gastrointestinal disease. Patients can purchase the test without a prescription from stores or Internet distributors in order to perform testing at home. Users obtain their own stool samples by wiping onto the test device, then develop the tests, read the test results, and send a report of the results to their physician. LifeGuard™ is useful as an aid in the diagnosis of a number of gastrointestinal disorders and is used for colorectal cancer screening programs. The American Cancer Society recommends that at least three consecutive bowel movements be tested due to the irregularity of bleeding from some intestinal lesions. Therefore, the LifeGuard™ home test kit includes three test wipes for testing three closely spaced bowel movements.
    Device Description
    The LifeGuard™ is a guaiac-based test for the qualitative detection of occult blood in stool.
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