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510(k) Data Aggregation

    K Number
    K974322
    Device Name
    ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM
    Manufacturer
    EUROPA SCIENTIFIC, LTD.
    Date Cleared
    1997-12-16

    (29 days)

    Product Code
    DOP
    Regulation Number
    862.2860
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROPA SCIENTIFIC, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ABCA-NT is a continuous flow Gas Isotope Ratio Mass Spectrometer (GIRMS) System intended for use in the measurement of stable isotopes of carbon, nitrogen, and oxygen in gas samples. For this purpose, the system is comprised of a gas sampling module, a gas purification module, and an isotope ratio mass spectrometer which are synchronously coupled by means of an external computer which also collects and archives data.
    Device Description
    The ABCA-NT is an acronym for a configuration of modules intended for use in analysis 13C and 18O in CO2 and 15N in N2 and N2O gas samples. The ABCA-NT System includes, as physically separate modules: - The Europa 20-20 continuous flow IRMS - The Europa ABCA-G gas purification module (Gas Chromatograph) - A Gilson (or equivalent) autosampler - An IBM (or compatible) personal computer for system control, data analysis and data storage
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