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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
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