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510(k) Data Aggregation

    K Number
    K210873
    Device Name
    Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20
    Manufacturer
    Oxoid Limited (part of Thermo Fisher Scientific)
    Date Cleared
    2021-10-27

    (217 days)

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

    Thermo Scientific Oxoid Lefamulin Disc (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 510(k) clearance letter for a medical device (Thermo Scientific Oxoid Lefamulin Disc (20μg) LMU20), which is an antimicrobial susceptibility test disc. This kind of document typically does not include detailed information about the acceptance criteria and the study that proves the device meets them, as it is a summary of the FDA's decision, not the full submission.

    Therefore, I cannot extract the requested information from the provided text.

    The document only states:

    • Device Name: Thermo Scientific Oxoid Lefamulin Disc (20μg) LMU20
    • Regulation Name: Antimicrobial Susceptibility Test Disc
    • Regulatory Class: Class II
    • Product Code: JTN

    To answer your questions, I would need access to the actual 510(k) submission document, which would contain the study protocols, results, and acceptance criteria.

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