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510(k) Data Aggregation

    K Number
    K073431
    Date Cleared
    2008-01-14

    (39 days)

    Product Code
    Regulation Number
    864.6550
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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