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510(k) Data Aggregation

    K Number
    K984513
    Device Name
    TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
    Manufacturer
    OXOID, LTD.
    Date Cleared
    1999-04-02

    (105 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 Trovafloxacin these include Haemophilus influenzae, Streptococcus pneumoniae and Neisseria gonorrhoeae.

    Device Description

    Oxoid Trovafloxacin Susceptibility Test Disc

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding an Antimicrobial Susceptibility Test Disc. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the format requested. The document primarily confirms the substantial equivalence of the device to a legally marketed predicate device and outlines regulatory responsibilities.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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