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510(k) Data Aggregation

    K Number
    K192326
    Device Name
    HardyDisk AST Lefamulin 20µg (LMU20)
    Manufacturer
    Hardy Diagnostics
    Date Cleared
    2019-09-19

    (23 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HardyDisk AST Lefamulin 20µg (LMU20)

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA clearance letter for a medical device (HardyDisk AST Lefamulin 20μg). It does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth establishment, or any of the specific technical details requested in the prompt.

    Therefore, I cannot fulfill the request using only the provided text. To answer your questions, I would need a different document, such as a study report, 510(k) summary, or a more detailed technical description of the device's performance characteristics.

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