FDA 510(k) Applications for Medical Device Product Code "CEM"
(Electrode, Ion Specific, Potassium)

FDA 510(k) Number Applicant Device Name Decision Date
K842786 ABBOTT DIAGNOSTICS DYNA-LYTE 2000 09/14/1984
K093318 ABBOTT LABORATORIES ACCELERATOR APS 02/19/2010
K993083 ABBOTT LABORATORIES ALCYON 300I (WITH ISE MODULE) ANALYZER 10/05/1999
K884566 ABBOTT LABORATORIES VISION LYTE (TM) POTASSIUM 12/02/1988
K850950 ABBOTT LABORATORIES VISION POTASSIUM 08/12/1985
K853531 AMERICAN DADE ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER 09/04/1985
K843008 AMERICAN MONITOR CORP. ION SELECTIVE ELECTRODES & REAGENT SYS 09/04/1984
K840887 AMERICAN RESEARCH PRODUCTS CO. AMRESCO E2A REAGENT SET 0562 & 0626 04/18/1984
K870033 AMERICAN RESEARCH PRODUCTS CO. AMRESCO FLOW PAC POTASSIUM REAGENT SET, #1460 01/21/1987
K870657 AVL SCIENTIFIC CORP. AVL MODEL 985 ELECTROLYTE ANALYZER 05/12/1987
K883240 AVL SCIENTIFIC CORP. AVL MODEL 986 ELECTROLYTE ANALYZER 09/22/1988
K974784 AVL SCIENTIFIC CORP. AVL OPTI CRITICAL CARE ANALYZER 02/24/1998
K896692 BAXTER HEALTHCARE CORP. AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER 01/02/1990
K900300 BAXTER HEALTHCARE CORP. LYTENING 2Z LYTENING SYSTEM 31 03/01/1990
K833776 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC QEA SODIUM/POTASSIUM ANALYZER 12/29/1983
K832036 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC QEA SODIUM/POTASSIUM ANALYZER 07/18/1983
K112412 BECKMAN COULTER, INC. AU5800(R) CHEMISTRY ANALYZER 12/23/2011
K042291 BECKMAN COULTER, INC. UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS 11/12/2004
K854298 BOEHRINGER MANNHEIM CORP. IRON 11/12/1985
K912649 BOEHRINGER MANNHEIM CORP. ISE/K+ 07/15/1991
K822441 BOEHRINGER MANNHEIM CORP. UNIMETER 330K 10/08/1982
K811310 CHEM-ELEC, INC. SODIUM/POTASSIUM REAGENT KITS 07/10/1981
K884769 CIBA CORNING DIAGNOSTICS CORP. MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY 01/17/1989
K040750 CLINICAL ANALYSIS CORPORATION, INC. BIO-CHEM ANALYZER, MODEL 100 10/28/2004
K771118 CLINICAL DIAGNOSTICS, INC. CENTRIA SEPARATION COLUMNS TYPE A 07/11/1977
K843239 COULTER ELECTRONICS, INC. DACOS PLUS LYTES OPTION 10/17/1984
K010061 DADE BEHRING, INC. DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND 03/14/2001
K970330 DADE INTL., INC. DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE 04/14/1997
K900788 DATACHEM, INC. MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER 07/05/1990
K800692 DIAGNOSTIC SOLUTIONS, INC. REAGENT FOR DETERM. POTASSIUM/IN HUMAN 05/28/1980
K121040 DIAMOND DIAGNOSTICS, INC. SMARTLYTE ELECTROLYTE ANALYZER 08/30/2012
K932044 DUPONT MEDICAL PRODUCTS DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD 07/27/1993
K800016 E.I. DUPONT DE NEMOURS & CO., INC. DUPONT "ACA" ION SELECTIVE ELECTRODE 01/21/1980
K800054 EASTMAN KODAK COMPANY KODAK EKTACHEM ELECTROLYTE ANALYZER 02/05/1980
K092849 EPOCAL, INC. BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER 03/30/2010
K790018 FISHER SCIENTIFIC CO., LLC. SERUM, POTASSIUM DETERMINATION OF 02/01/1979
K901039 FRESENIUS USA, INC. IONOMETER EH 06/28/1990
K901041 FRESENIUS USA, INC. IONOMETER EH-HK AND ACCESSORIES 06/18/1990
K771837 GAMMA ENTERPRISES, INC. POTASSIUM 11/02/1977
K923038 HERAEUS KULZER, INC. MILES POTASSIUM METHOD 08/24/1992
K851350 HI CHEM, INC. ION 2 REAGENT KI 04/29/1985
K833159 HI CHEM, INC. POTASSIUM ELECTRODE TIP ASSAMBLY-K- 11/25/1983
K791692 HI CHEM, INC. SODIUM/POTASSIUM BUFFER SOLUTION 09/17/1979
K844806 HORIBA INSTRUMENTS, INC. MODIFY ELECTROLYTE ANALYZER MODEL SERA-210 01/08/1985
K853356 HORIBA INSTRUMENTS, INC. SERA-210 ELECTROLYTE ANALYZER 09/03/1985
K853068 ILEX CORP. ILEX PROMPT CLINICAL CHEMISTRY ANALYER 10/31/1985
K121012 INPECO S.P.A. FLEXLAB 3.6, ACCELERATOR A3600 08/31/2012
K112995 INSTRUMENTATION LABORATORY CO. GEM PREMIER 4000 05/03/2012
K851808 IONETICS, INC. ELECTROLYTE ANALYZER 06/25/1985
K890792 IONETICS, INC. POTASSIUM AND SODIUM ELECTROLYTE ANALYZER 05/03/1989
K961115 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) 05/07/1996
K112788 MEDICA CORP. EASTLYTE NA/K/CA/PH 10/20/2011
K961326 MEDICA CORP. EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER 06/21/1996
K844044 MEDICA CORP. LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER 11/27/1984
K897110 MEDISENSE, INC. SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM 02/27/1990
K844955 MILES LABORATORIES, INC. SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, & 03/19/1985
K791175 NOVA BIOMEDICAL CORP. ANALYZER, SODIUM/POTASSIUM 08/10/1979
K915178 NOVA BIOMEDICAL CORP. NOVA 11 NA/K/LI ANALYZER 01/27/1992
K915177 NOVA BIOMEDICAL CORP. NOVA 5 NA/K/C1 ALALYZER 01/27/1992
K922943 NOVA BIOMEDICAL CORP. NOVA NA/K/CL/LI MODULE 10/13/1992
K073157 ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 12/07/2007
K083680 ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 02/27/2009
K061730 OSMETECH, INC. OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 08/04/2006
K802158 PANMED, INC. POSTASSIUM BUFFER SOL. & WASH SOLUTION 10/10/1980
K112408 POLYMEDCO, INC. POLY-CHEM 90 ISE MODULE 11/04/2011
K915345 PORTABLE DIAGNOSTIC SERVICES, INC. STAT K SYSTEM 07/16/1992
K833696 RADIOMETER AMERICA, INC. ACID BASE LABORATORY ABL4 01/18/1984
K092686 RADIOMETER MEDICAL APS ABL90 FLEX SERIES 08/06/2010
K052914 RANDOX LABORATORIES, LTD. RX IMOLA 03/31/2006
K060373 ROCHE DIAGNOSTICS COBAS 6000 SERIES SYSTEM 03/13/2006
K013373 ROCHE DIAGNOSTICS CORP. OMNI C ANALYZER 11/02/2001
K032311 ROCHE DIAGNOSTICS CORP. ROCHE DIAGNOSTICS OMNI S ANALYZER 10/17/2003
K830104 SCLAVO, INC. SERUM IRON DIAGNOSTIC TEST KITS 01/28/1983
K851100 SEN TECH MEDICAL CORP. CHEM PRO 1000 CHEMISTRY ANALYSIS 07/09/1985
K841575 SENTECH MEDICAL CORP. SENTECH'S ULAB 1000 CLINICAL CHEM. 07/06/1984
K854723 SMITH KLINE DIAGNOSTICS, INC. SKD ELECTROCHEMICAL SYSTEM (ECS) 03/05/1986
K042270 STAT CHEM, INC. STAT K IN VITRO DIAGNOSTIC TEST SYSTEM 10/06/2004
K895664 TECHNICON INSTRUMENTS CORP. TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD 11/14/1989
K061107 THERMO ELECTRON OY DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 08/08/2006
K821822 THERMO ORION MODEL 1020 NA/K ANALYZER 07/02/1982
K110520 TOKYO BOEKI MEDISYS INC. BIOLIS 12I 03/23/2012
K840961 U.S. SCIENCE, INC. ESCHWEILER COMBI-ANALYSER MTA-500 08/10/1984
K842315 ULTRA QUEST DIAGNOSTICS, INC. ULTRA LYTE ANALYZER I 100 08/02/1984
K843454 ULTRA QUEST DIAGNOSTICS, INC. ULTRA LYTE POTASSIUM REAGENT KIT 11/27/1984


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