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510(k) approval for Diametrics Medical:

This article was originally published in Clinica

Executive Summary

US company Diametrics Medical has received clearance to market its multi-use cartridge (IRMA-M), used in conjunction with the IRMA SL blood analysis system. The system is a handheld blood analyser which uses disposable cartridges to perform time-critical tests such as blood gases, electrolytes and hematocrit. The IRMA-M cartridge enhances this system by allowing multiple test panels to be performed on a single cartridge before disposal. The company expects to begin marketing the device later this year.





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