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510(k) Data Aggregation

    K Number
    K181700
    Device Name
    HardyDisk AST Plazomicin 30ug (PLZ30)
    Manufacturer
    Hardy Diagnostics
    Date Cleared
    2018-07-10

    (13 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter for the HardyDisk AST Plazomicin 30ug (PLZ30) Antimicrobial Susceptibility Test Disc. It does not contain information about acceptance criteria, device performance, or details of a study that proves the device meets specific acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

    Therefore, I cannot provide the requested information based on the given document.

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