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510(k) Data Aggregation

    K Number
    K052598
    Device Name
    IMMOCARE
    Manufacturer
    CARE DIAGNOSTIC, INC.
    Date Cleared
    2006-03-16

    (176 days)

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

    CARE DIAGNOSTIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ImmoCARE® test is a rapid, immunochromatographic assay for the qualitative detection of intact hHB (human hemoglobin) in fecal specimens. It is a convenient and hygienic inethod for detecting human fecal occult blood, which may be indicative of gastrointestinal diseases associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans. ImmoCARE® is an immunological test for both professional and over the counter use..
    Device Description
    The ImmoCARE® test is a rapid, immunochromatographic assay for the qualitative detection of intact hHB (human hemoglobin) in fecal specimens.
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