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510(k) Data Aggregation

    K Number
    K971631
    Device Name
    CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
    Manufacturer
    OXOID, LTD.
    Date Cleared
    1997-07-03

    (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 indicated for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriaceae, Enterococcus spp., and modified by procedures, Haemophilus influenzae and Neisseria gonorthoeae.

    Device Description

    Oxoid Cefotetan Susceptibility Test Disc

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot provide this information. The document is a 510(k) clearance letter from the FDA for a Cefotetan Antimicrobial Susceptibility Test Disc. It confirms that the device is substantially equivalent to previously marketed devices and allows it to proceed to market. However, it does not contain the detailed study results, acceptance criteria, or information about AI involvement that you are requesting. My purpose is to provide helpful and harmless information, and speculating about details not present in the document would be outside of my capabilities.

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