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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