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    K Number
    K203336
    Device Name
    Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
    Manufacturer
    Oxoid Limited (part of Thermo Fisher Scientific)
    Date Cleared
    2022-09-15

    (672 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 Omadacycline Disc (30 ug) OMC30

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    This document is not about a device that uses AI. It is an FDA clearance letter for a medical device (Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30) which is an antimicrobial susceptibility test disc. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI-specific metrics is not applicable and cannot be extracted from this document.

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