FDA 510(k) Applications for Medical Device Product Code: OMN ()

FDA 510(k) Applications for Medical Device Product Code "OMN"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K110203	CEPHEID	XPERT C. DIFFICLE/EPI ASSAY	04/07/2011
K113433	FOCUS DIAGNOSTICS, INC.	SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT	04/04/2012
DEN120013	GREAT BASIN SCIENTIFIC	PORTRAIT ANALYZER	04/30/2012
K110012	MERIDIAN BIOSCIENCE, INC.	ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10	02/24/2011
K100818	MERIDIAN BIOSCIENCE, INC.	ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920	07/09/2010