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

    SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS

    K Number: K052091 · Decision Sep 21, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    56
    Review Days
    50

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    Basic Information

    Device Name
    SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
    K Number
    K052091
    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
    August 2, 2005
    Decision Date
    September 21, 2005
    Product Code
    JWY
    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
    JWY Manual Antimicrobial Susceptibility Test Systems

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    Other Clearances by Trek Diagnostic Systems, Inc.

    K Number Device Name
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    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
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