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

    SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES

    K Number: K062190 · Decision Aug 31, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    56
    Review Days
    31

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    Basic Information

    Device Name
    SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
    K Number
    K062190
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trek Diagnostic Systems, Inc.
    Date Received
    July 31, 2006
    Decision Date
    August 31, 2006
    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.

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    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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