BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475

    K Number: K100060 · Decision Dec 15, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    85
    Applicant Total
    5
    Review Days
    338

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    Basic Information

    Device Name
    EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475
    K Number
    K100060
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vital Diagnostics (Manufacturing) Ptyltd
    Date Received
    January 11, 2010
    Decision Date
    December 15, 2010
    Product Code
    KHS
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KHS Enzymatic, Carbon-Dioxide

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    Other Clearances by Vital Diagnostics (Manufacturing) Ptyltd

    K Number Device Name
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