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

FDA 510(k) Number Applicant Device Name Decision Date
K993211 ABAXIS, INC. PICCOLO SODIUM TEST SYSTEM 10/25/1999
K213486 Abbott Laboratories GLP systems Track 03/10/2022
K153357 ABBOTT POINT OF CARE INC. i-STAT Alinity System with i-STAT Sodium test 07/08/2016
K183688 Abbott Point of Care, Inc. i-STAT CHEM8+ cartridge with the i-STAT 1 System 02/07/2020
K172232 AMS Diagnostics LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 06/12/2019
K171476 Awareness Technology, Inc. SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) 02/27/2018
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
K220977 Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer 07/20/2023
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
K002855 BIOCARE CORP. BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER 10/12/2000
K990036 CARESIDE, INC. CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 03/18/1999
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
K070104 DIAMOND DIAGNOSTICS, INC. PROLYTE ELECTROLYTE ANALYZER 05/07/2008
K102959 DIAMOND DIAGNOSTICS, INC. PROLYTE ELECTROLYTE ANALYZER 01/14/2011
K992844 ELAN HOLDINGS, INC. HICHEM ISE ELECTROLYTE BUFFER 11/26/1999
K992842 ELAN HOLDINGS, INC. HICHEM ISE ELECTROLYTE REFERENCE 11/26/1999
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
K061597 EPOCAL, INC. EPOC BLOOD ANALYSIS SYSTEM 09/27/2006
K040977 GENCHEM, INC. GENCHEM ELECTROLYTE BUFFER 12/27/2004
K040971 GENCHEM, INC. GENCHEM ISE ELECTROLYTE REFERENCE 12/22/2004
K001154 I-STAT CORP. I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER 04/18/2000
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
K183549 Instrumentation Laboratory Co. GEM Premier ChemSTAT 02/16/2019
K961099 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+) 05/07/1996
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
K963763 MEDICA CORP. EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER 11/29/1996
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
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
K191365 Nova Biomedical Corporation Stat Profile Prime ES Comp Plus Analyzer System 07/19/2019
K180428 Nova Biomedical Corporation Stat Profile Prime Plus Analyzer System 08/15/2018
K200403 Nova Biomedical Corporation Stat Profile Prime Plus Analyzer System 04/14/2020
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
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
K962334 RADIOMETER AMERICA, INC. EML105 ELECTROLYTE METABOLITE ANALYZER 10/24/1996
K963627 ROCHE DIAGNOSTIC SYSTEMS, INC. (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE 10/24/1996
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
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
K222438 Siemens Healthcare Diagnostics Inc. A-LYTE« Integrated Multisensor (IMT Na K Cl) 07/25/2023
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
K052724 TECO DIAGNOSTICS TECO ISE REAGENT SET FOR CX SYSTEM 12/14/2005


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