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    K Number
    K113506
    Device Name
    IND ONE STEP OCCULT BLOOD (FOB) TEST
    Manufacturer
    IND DIAGNOSTICS INC.
    Date Cleared
    2012-12-19

    (387 days)

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

    IND ONE STEP OCCULT BLOOD (FOB) TEST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The One Step Fecal Occult Blood (FOB) Test is a simple, direct binding immunoassay for the rapid and the qualitative detection of fecal occult blood by laboratories or physician's offices. It is useful to determine gastrointestinal bleeding found in gastrointestinal disorders. For professional in vitro diagnostic use only.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria, device performance, or any studies related to the IND One Step Fecal Occult Blood Test. The document is an FDA 510(k) clearance letter, which states that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the specific performance studies, acceptance criteria, or their results.

    Therefore, I cannot provide the requested information based on the input text.

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