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510(k) Data Aggregation

    K Number
    K984269
    Device Name
    DBEST OCCULT BLOOD TEST KIT
    Manufacturer
    AMERITEK, INC.
    Date Cleared
    1999-05-11

    (201 days)

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

    DBEST OCCULT BLOOD TEST KIT

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

    dBest Sensitive Occult Blood Test Kit is a simple in-vitro guaiac slide test assay for the rapid, qualitative detection of human occult blood in feces, as a useful aid for detection of bleeding caused by a number of gastrointestinal disorders. The dBest Sensitive Occult Blood Test Kit is for clinical situations and professional laboratory use only.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but after reviewing the provided document, I was unable to locate the information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria. The document appears to be a 510(k) clearance letter from the FDA for a device called "AmeriTek dBest Sensitive Occult Blood Test Kit". It outlines the regulatory classification, general controls, and permits marketing of the device, but it does not contain details about specific performance acceptance criteria or a study proving its performance.

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