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

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

FDA 510(k) Number	Applicant	Device Name	Decision Date
K123423	MERIDIAN BIOSCIENCE, INC.	ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT	06/05/2013
K160829	MERIDIAN BIOSCIENCE, INC.	illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10	06/13/2016
K152800	MERIDIAN BIOSCIENCE, INC.	illumigene Mycoplasma DNA Amplification Assay	10/23/2015