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510(k) Data Aggregation

    K Number
    K230890
    Device Name
    ISE Electrodes
    Manufacturer
    Randox Laboratories Ltd.
    Date Cleared
    2023-09-08

    (161 days)

    Product Code
    CEM, CGZ, JGS
    Regulation Number
    862.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    Randox Laboratories Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ISE Electrodes on the RX Imola can be used for measurement of the electrolytes sodium, potassium and chloride in serum and urine and for use in diagnosis and treatment of electrolyte imbalance. For in vitro diagnostic use only.
    Device Description
    RX imola is an automated clinical chemistry analyzer complete with dedicated analyzer software. Software functions of the analyzer include the facility to interact with a host computer for direct download of test method selection details for individual samples. A barcode system is used for the rapid identification of patient samples, reagents and QC samples, In addition, the RX imola is fitted with an Ion Selective Electrode (ISE) module that operates in conjunction with specific electrodes for the quantitative in vitro diagnostic determination of Sodium, Potassium and Chloride in serum and urine.
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    K Number
    K182042
    Device Name
    Randox Calcium (Ca)
    Manufacturer
    Randox Laboratories Ltd.
    Date Cleared
    2018-10-23

    (85 days)

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

    Randox Laboratories Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Randox Calcium (Ca) device is intended for the quantitative in vitro determination in serum, plasma and urine. This product is suitable for use on the RX series analyzer, RX daytona plus. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure.
    Device Description
    The Randox Calcium (Ca) kit consists of a ready to use reagent solution.
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