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510(k) Data Aggregation

    K Number
    K023792
    Device Name
    CALIBRATION PACK, MODELS A9100-101S AND A9100-103S
    Manufacturer
    THERMO ORION
    Date Cleared
    2003-01-31

    (79 days)

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

    THERMO ORION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The products encompassed by this request are intended for in vitro diagnostic use only and are intended for use in the calibration of equivalent Roche/AVL 9100 Series Electrolyte Analyzers.
    Device Description
    Thermo ALKO Calibration Packs are intended for use on equivalent Roche/AVL 9100 Series Analyzers. Calibration Pack, Product No. A9100-101S, contains Standard A, Standard B, Reference Solution and a waste container. It is intended for calibration of equivalent Roche/AVL 9120 and 9130 Analyzers, Calibration Pack, Product No. A9100-103S, contains Standard B, Standard C, Reference Solution and a waste container. It is intended for calibration of equivalent Roche/AVL 9180 and 9181 Analyzers.
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