BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SENSITITRE YEASTONE SUSCEPTIBILITY PLATES

    K Number: K133038 · Decision Jan 31, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    20
    Applicant Total
    5
    Review Days
    127

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    Basic Information

    Device Name
    SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
    K Number
    K133038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Trek Diagnostic Systems
    Date Received
    September 26, 2013
    Decision Date
    January 31, 2014
    Product Code
    NGZ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NGZ Susceptibility Test Plate, Antifungal

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    Other Clearances by Trek Diagnostic Systems

    K Number Device Name
    K112276 VIZION
    K111615 SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES
    K103532 AUTOREADER 2
    K103456 THE SENSITITRE AIM