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510(k) Data Aggregation

    K Number
    K984036
    Device Name
    NETILMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
    Manufacturer
    OXOID, LTD.
    Date Cleared
    1999-01-13

    (62 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

    Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Netilmicin these include Staphylococcus spp. Pseudomonas spp. and Escherichia coli.

    Device Description

    Oxoid Netilmicin Susceptibility Test Disc

    AI/ML Overview

    I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the Oxoid Netilmicin Susceptibility Test Disc, stating that the device is substantially equivalent to legally marketed predicate devices. It does not include performance data or details about specific acceptance criteria.

    Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

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