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510(k) Data Aggregation

    K Number
    K011814
    Device Name
    AMEDITECH IMMUTEST DRUG SCREEN COC
    Manufacturer
    AMEDITECH, INC.
    Date Cleared
    2001-10-22

    (133 days)

    Product Code
    DIO
    Regulation Number
    862.3250
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ameditech ImmuTest™ Drug Screen COC is an In Vitro screen test for the qualitative detection of benzoylecgonine (cocaine metabolite) in human urine at cut-off concentration of 300 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use.

    Device Description

    Not Found

    AI/ML Overview

    This document is the FDA's acceptance of Ameditech, Inc.'s 510(k) premarket notification for their ImmuTest™ Drug Screen COC. It does not contain information about the study or acceptance criteria.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document is an approval letter, not a study report or technical specification.

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