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510(k) Data Aggregation
K Number
K992163Device Name
ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS
Manufacturer
PDZ-EUROPA LTD.
Date Cleared
1999-07-13
(18 days)
Product Code
DOP
Regulation Number
862.2860Why did this record match?
Product Code :
DOP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ABCA 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 personal computer which also collects and archives data.
Device Description
The ABCA is an acronym for a configuration of modules intended for use in analysis ${}^{13}$C and ${}^{18}$O in CO${}_2$ and ${}^{15}$N in N${}_2$ and N${}_2$O gas samples. The ABCA System includes:
- The Europa 20-20 continuous flow IRMS
- A gas purification module (Gas Chromatograph)
- An autosampler
- An IBM (or compatible) personal computer for system control, data analysis and data storage
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K Number
K974322Device 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
862.2860Why did this record match?
Product Code :
DOP
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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