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news.Iris International has submitted a 510(k) application with the FDA for clearance to market its iChem Velocity automated urine chemistry analyzer utilizing the company's proprietary Kinetic Imaging technology.
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The iChem Velocity system is the first urinalysis system to employ Iris’s proprietary Kinetic Imaging technology that will optimize the sensitivity and dynamic range of the company’s urine chemistry strips.
Cesar Garcia, chairman, president and CEO of Iris, said: “While pursuing FDA approval, we are proceeding with the international launch of the iChem Velocity scheduled for March of 2008. This will allow us to market an integrated system with our iQ200 automated urine microscopy analyzer in the international marketplace for the first time.”