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 |