BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇦🇹 Austria

    VITAL SERUM CONTROLS

    K Number: K111063 · Decision Jun 28, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    5
    Review Days
    71

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    Basic Information

    Device Name
    VITAL SERUM CONTROLS
    K Number
    K111063
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vital Diagnostics (Manufacturing) Ptyltd
    Date Received
    April 18, 2011
    Decision Date
    June 28, 2011
    Product Code
    JJY
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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    Other Clearances by Vital Diagnostics (Manufacturing) Ptyltd

    K Number Device Name
    K120626 EON CALCIUM REGENT
    K112416 CPK REAGENT
    K110394 ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
    K100060 EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475