FDA 510(k) Applications for Medical Device Product Code: NUA (System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection)

FDA 510(k) Applications for Medical Device Product Code "NUA"
(System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K062028	CELERA DIAGNOSTICS	CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01	09/07/2007
K051435	CLINICAL MICRO SENSORS	ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800	01/19/2006
K060543	CLINICAL MICRO SENSORS, INC.	ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800	03/28/2006
K083845	LUMINEX MOLECULAR DIAGNOSTICS, INC.	XTAG CF60 KIT V2	12/11/2009
K163347	Luminex Molecular Diagnostics, Inc.	xTAG Cystic Fibrosis 39 Kit v2	12/15/2016
K083846	LUMINEX MOLECULAR DIAGNOSTICS, INC.	XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267	09/01/2009
K163336	Luminex Molecular Diagnostics, Inc.	xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR	12/15/2016
K083294	NANOSPHERE, INC	VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST	07/24/2009
K090901	OSMETECH MOLECULAR DIAGNOSTICS	ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8	07/06/2009
K063787	THIRD WAVE TECHNOLOGIES, INC.	INPLEX CF MOLECULAR TEST	03/13/2008
K060627	TM BIOSCIENCE CORPORATION	TAG-IT CYSTIC FIBROSIS KIT	06/07/2006
DEN050004	TM BIOSCIENCE CORPORATION	TAG-IT CYSTIC FIBROSIS KIT	05/09/2005