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510(k) Data Aggregation

    K Number
    K051806
    Device Name
    CARE FECAL OCCULT BLOOD TEST, MODEL KT313
    Manufacturer
    EPITOPE DIAGNOSTICS, INC.
    Date Cleared
    2005-10-03

    (90 days)

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

    EPITOPE DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Epitope Diagnostics CARE™ Fecal Occult Blood Test Device is a rapid immunological test intended for the qualitative detection of fecal occult blood in feces by professional laboratories and physician office laboratories. The test is intended for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer. The CARE™ Fecal Occult Blood Test Device is recommended for use in (1) routine physical examinations, (2) monitoring any bleeding in patients, and (3) screening for colorectal cancer or gastrointestinal bleeding.
    Device Description
    Not Found
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