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

    EON CALCIUM REGENT

    K Number: K120626 · Decision Aug 22, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    46
    Applicant Total
    5
    Review Days
    174

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    Basic Information

    Device Name
    EON CALCIUM REGENT
    K Number
    K120626
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1145
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vital Diagnostics (Manufacturing) Ptyltd
    Date Received
    March 1, 2012
    Decision Date
    August 22, 2012
    Product Code
    CJY
    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
    CJY Azo Dye, Calcium

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    Other Clearances by Vital Diagnostics (Manufacturing) Ptyltd

    K Number Device Name
    K112416 CPK REAGENT
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    K110394 ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
    K100060 EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475