FDA 510(k) Applications for Medical Device Product Code: NSU (Instrumentation For Clinical Multiplex Test Systems)

FDA 510(k) Applications for Medical Device Product Code "NSU"
(Instrumentation For Clinical Multiplex Test Systems)

FDA 510(k) Number	Applicant	Device Name	Decision Date
DEN040012	Affymetrix, Inc.	AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM	12/23/2004
K080995	Affymetrix, Inc.	MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM	07/30/2008
K082562	APPLIED BIOSYSTEMS INC	APPLIED BIOSYSTEMS 7500 FAST DX	09/30/2008
K143178	BioFire Diagnostics, LLC	FilmArray 2.0 System	01/30/2015
K110786	GENMARK DIAGNOSTICS, INC	ESENSOR WARFARIN SENSITIVITY SALIVA TEST	12/02/2011
K163652	GenMark Diagnostics, Incorporated	ePlex Instrument	06/09/2017
K093128	ILLUMINA, INC.	ILLUMINA BEADXPRESS SYSTEM	04/28/2010
K133849	LIPOSCIENCE	VANTERA CLINICAL ANALYZER	10/22/2014
K133302	LUMINEX CORP.	FLEXMAP 3D	01/10/2014
K121399	LUMINEX CORP.	LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P	01/09/2013
K073506	LUMINEX CORP.	LUMINEX LX 100/200 INSTRUMENT	03/07/2008
K070597	NANOSPHERE, INC	VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST	10/11/2007
K141220	THERMO FISHER SCIENTIFIC (LIFE TECHNOLOGIES HOLDIN	APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE	05/22/2014