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510(k) Data Aggregation

    K Number
    K120626
    Device Name
    EON CALCIUM REGENT
    Manufacturer
    VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
    Date Cleared
    2012-08-22

    (174 days)

    Product Code
    CJY
    Regulation Number
    862.1145
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vital Diagnostics Eon Calcium Reagent is a device intended to measure the total calcium level in serum and plasma using the Eon 100 Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
    Device Description
    Not Found
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    K Number
    K110394
    Device Name
    ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
    Manufacturer
    VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
    Date Cleared
    2011-06-09

    (118 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATAC Serum Calibrator is intended for use with the ATAC Clinical Systems to establish points of reference that are used in the determination of albumin, calcium, cholesterol, creatinine, direct bilirubin, glucose, iron, magnesium, phosphorus, total bilirubin, total protein, triglycerides, urea and uric acid in human specimens.
    Device Description
    Not Found
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    K Number
    K100060
    Device Name
    EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475
    Manufacturer
    VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
    Date Cleared
    2010-12-15

    (338 days)

    Product Code
    KHS, CEK, CEM, CGZ, CIX, JFJ, JGS, JIT, JIX, JJE, KNK
    Regulation Number
    862.1160
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Eon 100 is a discrete photometric chemistry analyzer for clinical use. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays. The Eon 100 has replaceable parts, automated maintenance monitoring and backup of both patient and system data. The Eon 100 Chemistry Analyzer is intended to be used to assist the clinician with the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease. The Eon 100 includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium and chloride in serum and plasma. The Eon 100 is for in vitro diagnostic use only.
    Device Description
    The Eon 100 is a discrete photometric chemistry analyzer for clinical use. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays. The Eon 100 has replaceable parts, automated maintenance monitoring and backup of both patient and system data. The Eon 100 includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium and chloride in serum and plasma.
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