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510(k) Data Aggregation

    K Number
    K983860
    Device Name
    MTM BIOSCANNER K TEST STRIPS, CAT # BSA610
    Manufacturer
    POLYMER TECHNOLOGY SYSTEMS, INC.
    Date Cleared
    1999-12-27

    (420 days)

    Product Code
    JMK
    Regulation Number
    862.1380
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MTM BioScanner K Test Strips are intended for the quantitative measurement of ketones in capillary whole blood in physicians office labs and at the bedside by professionals and at home by lay users.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA 510(k) clearance letter for the "MTM BioScanner K Test Strips." It does not include a study or information about acceptance criteria and device performance.

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