FDA 510(k) Applications for Medical Device Product Code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)

FDA 510(k) Applications for Medical Device Product Code "JJE"
(Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K974779	ABBOTT LABORATORIES	ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER	02/13/1998
K974651	ABBOTT LABORATORIES	ABBOTT AXSYM SYSTEM	02/12/1998
K113253	ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.	ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT	05/17/2012
K983345	BAYER CORP.	BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY	12/07/1998
K962125	BAYER CORP.	TECHNICON IMMUNO 1 SYSTEM	08/02/1996
K023764	BECKMAN COULTER, INC.	UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100	01/28/2003
K965240	BECKMAN INSTRUMENTS, INC.	SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L	03/10/1997
K971761	BIOCHEM IMMUNOSYSTEMS (U.S.), INC.	PERSONALLAB AUTOMATED MICROPLATE ANALYZER	07/22/1997
K961481	BOEHRINGER MANNHEIM CORP.	ELECSYS 2010 ANALYZER	06/14/1996
K133519	CAROLINA LIQUID CHEMISTRIES CORP.	CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR	05/16/2014
K051087	DADE BEHRING, INC.	DIMENSION VISTA INTEGRATED SYSTEM	07/11/2005
K970227	DPC CIRRUS	IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER	04/08/1997
K183375	Horiba, Ltd	Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode	02/12/2019
K130915	JAS Diagnostics, Inc.	XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK	05/15/2014
K962235	JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.	VITROS SPECIALTY DILUENT	06/26/1996
K010500	LAB-INTERLINK, INC.	AUTOMATED WORKCELL CONTROL SOFTWARE	08/01/2001
K961142	NICHOLS INSTITUTE DIAGNOSTICS	STRATEC LIA II ANALYZER	02/18/1997
K003721	OLYMPUS AMERICA, INC.	MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER	12/18/2000
K002982	OLYMPUS AMERICA, INC.	OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER	10/25/2000
K961274	OLYMPUS AMERICA, INC.	OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER	07/05/1996
K063144	Ortho-Clinical Diagnostics, Inc.	VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM	11/13/2006
K131554	RANDOX LABORATORIES, LTD.	RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT	01/09/2014
K962231	ROCHE DIAGNOSTIC SYSTEMS, INC.	COBAS CORE IMMUNOCHEMISTRY SYSTEM	08/30/1996
K112999	SIEMENS HEALTHCARE DIAGNOSTICS	DIMENSION CLINICAL CHEMISTRY SYSTEM	11/22/2011
K130276	SIEMENS HEALTHCARE DIAGNOSTICS, INC.	DIMENSION EXL WITH LM SYSTEM	03/22/2013
K963539	SIGMA DIAGNOSTICS, INC.	SIGMA DIAGNOSTICS WASH CONCENTRATE	12/16/1996
K042169	STANBIO LABORATORY	STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER	03/14/2005
K073370	TECO DIAGNOSTICS	TC MATRIX CLINICAL CHEMISTRY ANALYZER	05/08/2008
K110035	THERMO FISHER SCIENTIFIC OY	INDIKO	06/28/2011
K040958	TOKYO BOEKI MEDICAL SYSTEM LTD.	PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240	02/15/2005

FDA 510(k) Applications for Medical Device Product Code "JJE" (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)

FDA 510(k) Applications for Medical Device Product Code "JJE"
(Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)