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

FDA 510(k) Number Applicant Device Name Decision Date
K873126 A-KEM, INC. SODIUM/POTASSIUM REAGENT KIT 10/23/1987
K993211 ABAXIS, INC. PICCOLO SODIUM TEST SYSTEM 10/25/1999
K810135 ABBOTT DIAGNOSTICS MODEL AM 721 ELECTROLYTE ANALYZER 02/10/1981
K903188 ABBOTT LABORATORIES ABBOTT VISION LYTE (TM) SODIUM 09/10/1990
K153357 ABBOTT POINT OF CARE INC. i-STAT Alinity System with i-STAT Sodium test 07/08/2016
K853832 AMDEV, INC. LYTENING 1 10/04/1985
K863521 AMDEV, INC. LYTENING 2 11/05/1986
K880917 AMDEV, INC. LYTENING 5 05/27/1988
K873074 AMERICAN MONITOR CORP. SODIUM AND POTASSIUM BY ION SELECTIVE 10/20/1987
K820395 AMERICAN RESEARCH PRODUCTS CO. "LIQUIZYME NA+/K+ REAGENT SET 03/11/1982
K861967 AMERICAN RESEARCH PRODUCTS CO. AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT SET 06/13/1986
K832070 AMERICAN RESEARCH PRODUCTS CO. AMRESCO NA/K REAGENT SET 08/12/1983
K833036 AMERICAN RESEARCH PRODUCTS CO. FLOW-PAC SODIUM REAGENT SET 11/07/1983
K844587 AVL SCIENTIFIC CORP. AVL MODEL 982 ELECTROLYTE ANALYZER 01/18/1985
K861087 AVL SCIENTIFIC CORP. AVL MODEL 983 ELECTROLYTE ANALYZER 04/07/1986
K862819 AVL SCIENTIFIC CORP. AVL MODEL 984 ELECTROLYTE ANALYZER 08/29/1986
K171476 Awareness Technology, Inc. SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) 02/27/2018
K910554 BAXTER HEALTHCARE CORP. CLINAK(TM) ISE SUBSYSTEM 03/06/1991
K896526 BAXTER HEALTHCARE CORP. LYTENING(TM) 5, LYTENING(TM) SYSTEM 30 01/02/1990
K990346 BAYER CORP. BAYER ADVIA 1650 CHEMISTRY SYSTEM 05/21/1999
K161837 BECKMAN COULTER INC. ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer 12/16/2016
K011213 BECKMAN COULTER, INC. MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM 05/16/2001
K023049 BECKMAN COULTER, INC. SYNCHRON LX I 725 CLINICAL SYSTEM 10/04/2002
K822039 BECKMAN INSTRUMENTS, INC. BECKMAN ASTRA 10/21/1982
K801896 BECKMAN INSTRUMENTS, INC. BECKMAN ELECTROLYTE-2 SODIUM/POTASSIUM 09/16/1980
K002855 BIOCARE CORP. BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER 10/12/2000
K904335 BIONOSTICS, INC. SECONDARY CALIBRATORS 10/12/1990
K861696 BOEHRINGER MANNHEIM CORP. ELECTROLYTE ANALYZER ACCESSORY FOR HITACHI 704 07/01/1986
K912648 BOEHRINGER MANNHEIM CORP. ISE/NA+ 07/17/1991
K990036 CARESIDE, INC. CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 03/18/1999
K933373 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING 300 SERIES SYSTEM 08/19/1993
K892500 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE 07/20/1989
K872716 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MODEL 580 ALLIANCE I.S.E. MODULE 07/31/1987
K871028 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MODEL 664/FAST 4 SYSTEM 05/28/1987
K811896 CORNING MEDICAL & SCIENTIFIC 902 NA/K 07/23/1981
K843530 CORNING MEDICAL & SCIENTIFIC CORNING 614 NA/K ANALYZER 12/11/1984
K874185 COULTER ELECTRONICS, INC. DART (R) ELECTROLYTE REAGENT SYSTEM 11/04/1987
K852595 DIAGNOSTIC CHEMICALS, LTD. (USA) DC-3 FLUIDS PACK, DC-5 FLUIDS PACK 07/12/1985
K842873 DIAGNOSTIC CHEMICALS, LTD. (USA) STANDARDS & ACCESSORIES FOR NOVA INSTRU 10/05/1984
K800676 DIAGNOSTIC SOLUTIONS, INC. REAGENTS FOR DETERM. SODIUM IN HUMAN SUM 05/28/1980
K121140 DIAMOND DIAGNOSTICS, INC PROLYTE ELECTROLYTE ANALYZER 08/22/2012
K082462 DIAMOND DIAGNOSTICS, INC. GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ 02/06/2009
K102959 DIAMOND DIAGNOSTICS, INC. PROLYTE ELECTROLYTE ANALYZER 01/14/2011
K070104 DIAMOND DIAGNOSTICS, INC. PROLYTE ELECTROLYTE ANALYZER 05/07/2008
K800628 EASTMAN KODAK COMPANY KODAK EKTACHEM CLINICAL CHEM. SLIDES 04/10/1980
K924471 EASTMAN KODAK COMPANY KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL) 11/06/1992
K992844 ELAN HOLDINGS, INC. HICHEM ISE ELECTROLYTE BUFFER 11/26/1999
K992842 ELAN HOLDINGS, INC. HICHEM ISE ELECTROLYTE REFERENCE 11/26/1999
K832744 ELECTRO-NUCLEONICS LABORATORIES, INC. STARLYTE 11/03/1983
K102647 ELITECHGROUP VITAL SCIENTIFIC BV ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... 03/24/2011
K894035 EOS TECHNOLOGY CORP. EOS CHEMISTRY ANALYZER 10/31/1989
K061597 EPOCAL, INC. EPOC BLOOD ANALYSIS SYSTEM 09/27/2006
K833712 FISHER SCIENTIFIC CO., LLC. NA/K FLUIDA PACK FOR NOVA 1 ANALYZER 01/13/1984
K800216 FISHER SCIENTIFIC CO., LLC. SODIUM/POTASSIUM CONDITIONING REAGENT 02/26/1980
K843452 FISHER SCIENTIFIC CO., LLC. STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ 09/27/1984
K901042 FRESENIUS USA, INC. IONOMETER EF-HK AND ACCESSORIES 07/31/1990
K901040 FRESENIUS USA, INC. IONOMETER EH-F AND ACCESSORIES 07/19/1990
K771839 GAMMA ENTERPRISES, INC. SODIUM 11/02/1977
K801011 GAUNTLET TECHNOLOGY CORP. AVL #980 ELECTROLYTE ANALYZER 07/08/1980
K040977 GENCHEM, INC. GENCHEM ELECTROLYTE BUFFER 12/27/2004
K040971 GENCHEM, INC. GENCHEM ISE ELECTROLYTE REFERENCE 12/22/2004
K864862 HF SCIENTIFIC, INC. REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA. 02/20/1987
K882801 HF SCIENTIFIC, INC. RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN. 08/29/1988
K863617 HI CHEM, INC. ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) 10/24/1986
K842025 HI CHEM, INC. ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL 06/22/1984
K791691 HI CHEM, INC. SODIUM/POTASSIUM CONDITIONING SOLUTION 09/17/1979
K925612 HICHEM DIAGNOSTICS HI CHEM ELECTROLYTE BUFFER 04/20/1993
K925611 HICHEM DIAGNOSTICS HI CHEM ELECTROLYTE REFERENCE REAGENT 02/23/1993
K841424 HORIBA INSTRUMENTS, INC. ELECTROLYTE ANALYZER SERA-210 06/22/1984
K912387 I-STAT CORP. I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK 07/01/1991
K001154 I-STAT CORP. I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER 04/18/2000
K894914 I-STAT CORP. MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK 10/16/1989
K053110 I-STAT CORPORATION I-STAT CHEM8 + CARTRIDGE 01/13/2006
K181201 Infrared Laboratory Systems, LLC (dba Synermed) Synermed ISE Reagents 07/10/2018
K160225 INSTRUMENTATION LABORATORY CO. GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator 12/14/2016
K812762 INSTRUMENTATION LABORATORY CO. IL 501, NA/K ANALYZER 10/20/1981
K912016 INSTRUMENTATION LABORATORY CO. IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER 06/10/1991
K801007 INSTRUMENTATION LABORATORY CO. IL SYSTEM 502 NA/K ANALYZER 05/14/1980
K932179 IONETICS, INC. MODEL 400/450 ELECTROLYTE ANALYZER 11/17/1993
K863907 IONETICS, INC. MODIFIED SODIUM ELECTRODE 12/10/1986
K801795 J.T. BAKER CHEMICAL CO. BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. 09/16/1980
K961099 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+) 05/07/1996
K910305 MALLINCKRODT SENSOR SYSTEMS, INC. GEM-PREMIER SYSTEM 04/03/1991
K002407 MEDICA CORP. EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER 02/02/2001
K100673 MEDICA CORP. EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020 04/06/2010
K895936 MEDICA CORP. EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER 12/12/1989
K963763 MEDICA CORP. EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER 11/29/1996
K914810 MEDICA CORP. EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER 12/04/1991
K100829 MEDICA CORP. EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520 01/14/2011
K955375 MEDICA CORP. EASYSTAT SODIUM/POTASSIUM ANALYZER 02/23/1996
K955374 MEDICA CORP. EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER 02/23/1996
K864872 MEDICA CORP. MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER 03/13/1987
K903564 MEDTEST SYSTEMS, INC. MEDISENSOR 2001 09/30/1991
K800584 NOBEL SCIENTIFIC INDUSTRIES, INC. NSI SODIUM/POTASSIUM KIT 04/02/1980
K770601 NOVA BIOMEDICAL CORP. ANALYZER, SODIUM/POTASSIUM NOVA L 06/14/1977
K923806 NOVA BIOMEDICAL CORP. ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER 09/29/1992
K912559 NOVA BIOMEDICAL CORP. NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZER 07/01/1991
K912560 NOVA BIOMEDICAL CORP. NOVA 12 ANALYZER 07/17/1991
K881255 NOVA BIOMEDICAL CORP. NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA 05/16/1988
K872190 NOVA BIOMEDICAL CORP. NOVA 13 SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER 06/24/1987
K922215 NOVA BIOMEDICAL CORP. NOVA 14 NA/K/CL/GLU/BUN ANALYZER 07/17/1992
K915176 NOVA BIOMEDICAL CORP. NOVA 4 NA/K/C1/TCO2/LI ANALYZER 01/15/1992
K801882 NOVA BIOMEDICAL CORP. NOVA 4 SODIUM/POTASSIUM/CHLORIDE/CARBON 09/16/1980
K811289 NOVA BIOMEDICAL CORP. NOVA 5 05/27/1981
K924547 NOVA BIOMEDICAL CORP. NOVA 8 CRT ANALYZER 01/28/1993
K921937 NOVA BIOMEDICAL CORP. NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATION 07/27/1992
K894218 NOVA BIOMEDICAL CORP. NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM 09/07/1989
K874832 NOVA BIOMEDICAL CORP. NOVA STAT PROFILE 5 ANALYZER + QUALITY CONTROL 02/11/1988
K880750 NOVA BIOMEDICAL CORP. NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT 07/01/1988
K905264 NOVA BIOMEDICAL CORP. STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS 03/05/1991
K000895 NOVA BIOMEDICAL CORP. STAT PROFILE PHOX PLUS ANALYZER 04/17/2000
K001761 NOVA BIOMEDICAL CORP. STATLYTE NA/K/CL/LI ANALYZER 08/07/2000
K180428 Nova Biomedical Corporation Stat Profile Prime Plus Analyzer System 08/15/2018
K921718 OLYMPUS CORP. OLYMPUS ISE MODULE 07/21/1992
K081411 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 06/30/2008
K091861 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927 09/03/2009
K802155 PANMED, INC. REAGENTS SERUM SODIUM USING THE TECH. 10/10/1980
K882104 PARAMAX SYSTEMS DIV. BAXTER HEALTHCARE ION SELECTIVE ELECTRODE SUBSYSTEM OF PARA. ANALYT. 07/05/1988
K020364 PHOENIX DIAGNOSTICS, INC. PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS 06/04/2002
K051646 POINTE SCIENTIFIC, INC. ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH 10/07/2005
K935120 RADIOMETER AMERICA, INC. EML 100 04/26/1994
K962334 RADIOMETER AMERICA, INC. EML105 ELECTROLYTE METABOLITE ANALYZER 10/24/1996
K841417 REAGENT LABORATORY, INC. POTASSIUM CHLORIDE SOLUTION -2 MOLAR 05/16/1984
K841418 REAGENT LABORATORY, INC. SODIUM ELECTRODE RINSE SOLUTION 2 05/16/1984
K963627 ROCHE DIAGNOSTIC SYSTEMS, INC. (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE 10/24/1996
K852473 ROCHE DIAGNOSTIC SYSTEMS, INC. ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA 07/12/1985
K123726 Roche Diagnostics COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 05/21/2013
K132418 Roche Diagnostics COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 12/18/2013
K140373 Roche Diagnostics ISE INDIRECT NA, K, C1 FOR GEN 2 05/22/2014
K053165 ROCHE DIAGNOSTICS CORP. ISE INDIRECT NA, K, CL FOR GEN.2 12/14/2005
K933862 SCHIAPPARELLI BIOSYSTEMS, INC. ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE) 10/12/1993
K850209 SERAGEN DIAGNOSTICS, INC. QUICK-LYTE 02/27/1985
K832415 SHABAN MFG. CO. DEPROTEINIZING & CLEANING SOLUTION 09/12/1983
K830589 SHABAN MFG. CO. ELECTROLYTE STANDARD - CORNING NALK ISE 04/27/1983
K830588 SHABAN MFG. CO. POTASSIUM ANALYZER-SODIUM/ELECTROLYTE 04/27/1983
K840557 SHABAN MFG. CO. REAGENTS & STANDARDS IL 501 NA/K 04/04/1984
K160370 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer 06/09/2016
K161954 Siemens Healthcare Diagnostics Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) 03/09/2017
K151767 SIEMENS HEALTHCARE DIAGNOSTICS, INC. Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator 12/11/2015
K963542 SIGMA DIAGNOSTICS, INC. SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT 09/27/1996
K870183 SMASH ENT., INC. IONOMETER EF AND ACCESSORIES 05/12/1987
K940194 SYNERMED, INC. SYNERMED ISE REAGENTS 04/05/1994
K941400 SYNERMED, INC. SYNERMED ISE REAGENTS 04/26/1994
K952179 SYNERMED, INC. SYNERMED ISE REAGENTS 06/20/1995
K905600 TECHNALYSIS, INC. TECHLYTE ELECTROLYTE ANALYZER 01/15/1991
K875263 TECHNICON INSTRUMENTS CORP. ANALYTES SODIUM & POTASSIUM ASSAYED ON TECH RA(R) 02/08/1988
K895672 TECHNICON INSTRUMENTS CORP. TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD 10/25/1989
K833072 TECHNICON INSTRUMENTS CORP. TECHNICON RA-1000 SYS-ISE MODULE & 11/14/1983
K833992 TECHNICON INSTRUMENTS CORP. TECHNICON RA-1000 SYSTEM 01/24/1984
K052724 TECO DIAGNOSTICS TECO ISE REAGENT SET FOR CX SYSTEM 12/14/2005
K844559 THERMO ORION MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTI 01/18/1985
K843453 ULTRA QUEST DIAGNOSTICS, INC. ULTRA LYTE SODIUM REAGENT KIT 11/27/1984


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