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.