LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K973487
    Device Name
    CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
    Manufacturer
    OXOID, LTD.
    Date Cleared
    1997-10-06

    (21 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 by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus spp.

    Device Description

    Not Found

    AI/ML Overview

    This FDA document is a 510(k) clearance letter for the Oxoid Cefpodoxime Antimicrobial Susceptibility Test Disc. It does not contain a detailed study report with acceptance criteria and device performance. The letter simply states that the device is "substantially equivalent" to predicate devices.

    Therefore, I cannot extract the requested information from the provided text as it is not present. The document focuses on regulatory approval based on substantial equivalence, not on the detailed results of a performance study.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1