LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974394
    Device Name
    ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
    Manufacturer
    OXOID, LTD.
    Date Cleared
    1998-01-14

    (55 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. These include : Enterobacteriaceae, Staphylococcus spp. and Pseudomonas spp., and by modified procedures, Neisseria gonorrhoeae.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for the Oxoid Enoxacin Susceptibility Test Disc, along with a portion of the 510(k) submission itself.

    The document does not contain any information about acceptance criteria or the study that proves the device meets those criteria. It is solely a regulatory approval document.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the other questions about study design, sample sizes, ground truth, or expert qualifications, as that information is not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1