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

    CPK REAGENT

    K Number: K112416 · Decision Nov 9, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    122
    Applicant Total
    5
    Review Days
    79

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    Basic Information

    Device Name
    CPK REAGENT
    K Number
    K112416
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vital Diagnostics (Manufacturing) Ptyltd
    Date Received
    August 22, 2011
    Decision Date
    November 9, 2011
    Product Code
    CGS
    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
    CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

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    Other Clearances by Vital Diagnostics (Manufacturing) Ptyltd

    K Number Device Name
    K120626 EON CALCIUM REGENT
    K111063 VITAL SERUM CONTROLS
    K110394 ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
    K100060 EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475