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    K Number
    K971638
    Device Name
    CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
    Manufacturer
    OXOID, LTD.
    Date Cleared
    1997-08-20

    (110 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

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

    Antimicrobial Susceptibility Test Discs are indicated for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Staphylococcus spp., Maraxella catarrhalis, and some Streptococci, and by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae.

    Device Description

    Oxoid Clarithromycin Susceptibility Test Disc

    AI/ML Overview

    This document is a marketing approval letter for a medical device (Oxoid Clarithromycin Susceptibility Test Disc) and does not contain the detailed study information required to answer the prompt. It confirms the device's substantial equivalence to a predicate device and permits its marketing.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, and ground truth establishment from the given text.

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