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

    ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)

    K Number: K110394 · Decision Jun 9, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    301
    Applicant Total
    5
    Review Days
    118

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    Basic Information

    Device Name
    ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
    K Number
    K110394
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vital Diagnostics (Manufacturing) Ptyltd
    Date Received
    February 11, 2011
    Decision Date
    June 9, 2011
    Product Code
    JIX
    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
    JIX Calibrator, Multi-Analyte Mixture

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    Other Clearances by Vital Diagnostics (Manufacturing) Ptyltd

    K Number Device Name
    K120626 EON CALCIUM REGENT
    K112416 CPK REAGENT
    K111063 VITAL SERUM CONTROLS
    K100060 EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475