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

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

FDA 510(k) Number	Applicant	Device Name	Decision Date
K163085	Focus Diagnostics, Inc.: DBA DiaSorin Molecular LLC	Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack	02/14/2017
K130470	GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)	BD MAX CDIFF ASSAY, BD MAX INSTRUMENT	04/02/2013
K172569	GenePOC Inc.	GenePOC CDiff	11/22/2017
K132235	Intelligent Medical Devices, Inc.	IMDX C.DIFFICILE FOR ABBOTT M2000	10/11/2013
K171441	Luminex Corporation	ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit	07/21/2017
K123197	NANOSPHERE, INC	VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)	12/05/2012
K132726	PRIMERADX	ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM	11/29/2013
K133936	QIAGEN, GMBH	ARTUS C. DIFFICILE QS-RGQ MDX KIT	04/04/2014
K123998	QUIDEL CORP.	QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY	03/08/2013
K123355	QUIDEL CORPORATION	AMPLIVUE C. DIFFICILE ASSAY	12/13/2012
K170491	Quidel Corporation	Solana C. difficile Assay	05/11/2017
K171770	Roche Molecular Systems, Inc.	cobas Cdiff Nucleic acid test for use on the cobas Liat System	09/12/2017
K210385	Roche Molecular Systems, Inc.	cobas Cdiff nucleic acid test for use on the cobas Liat System	09/09/2021
K212427	Roche Molecular Systems, Inc.	cobas Cdiff nucleic acid test for use on the cobas Liat System	10/20/2021
K142422	ROCHE MOLECULAR SYSTEMS, INC.	cobas Cdiff Test	05/20/2015
K232092	Vela Operations USA	Great Basin Toxigenic C. difficile Direct Test (CDF2)	11/14/2023