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

    SENSITITRE YEASTONE SUSCEPTIBILITY PLATES

    K Number: K090968 · Decision Jun 4, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    20
    Applicant Total
    56
    Review Days
    59

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    Basic Information

    Device Name
    SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
    K Number
    K090968
    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, Inc.
    Date Received
    April 6, 2009
    Decision Date
    June 4, 2009
    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, Inc.

    K Number Device Name
    K093865 SENSITITRE 18-24HR SUSCEPTIBILITY PLATES
    K083606 SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES
    K081063 SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
    K081520 SENSITITRE VIZION
    K073653 SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE
    K073558 SENSITITRE 18-24 SUSCEPTIBILITY PLATE
    K073424 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
    K062841 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES
    K062839 MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
    K062816 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
    Search all 56 clearances from Trek Diagnostic Systems, Inc. →