FDA 510(k) Applications Submitted by Michelle L Smith

FDA 510(k) Number	Submission Date	Device Name	Applicant
K110012	01/03/2011	ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10	MERIDIAN BIOSCIENCE, INC.
K090700	03/17/2009	IMMUNOCARD STAT CAMPY, MODEL 751530	MERIDIAN BIOSCIENCE, INC.
K100818	03/23/2010	ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920	MERIDIAN BIOSCIENCE, INC.
K121044	04/06/2012	ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM	MERIDIAN BIOSCIENCE, INC.
K122019	07/10/2012	STREPTOCOCCUS APP. SEROLOGICAL REAGENTS	MERIDIAN BIOSCIENCE, INC.
K123423	11/06/2012	ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT	MERIDIAN BIOSCIENCE, INC.
K133673	11/29/2013	ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA	MERIDIAN BIOSCIENCE, INC.
K160829	03/25/2016	illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10	MERIDIAN BIOSCIENCE, INC.