Peptic Ulcer Disease

FDA issues 510(k) clearance for POCone infrared spectrophotometer

Published in Medical Letter on the CDC and FDA, August 29th, 2004

Meretek Diagnostics Inc. announced that Otsuka Pharmaceutical Co., Ltd., received U.S. Food and Drug Administration (FDA) clearance of its 510(k) application to market the POCone Infrared Spectrophotometer.

The POCone is a new instrument that offers several technological advancements to aid in the detection of active H. pylori infection, and to confirm eradication of infection through the patented 13C urea breath test technology and methodology.

The POCone is an in-vitro diagnostic device designed to measure the change of 13CO2 concentration in breath by infrared spectroscopic analysis and is intended for use in conjunction with the BreathTek urea...

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Source: Medical Letter on the CDC and FDA (2004-08-29)

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