Panels › Clinical Chemistry › Product code JGS · Class 2
Electrode, Ion Specific, Sodium
Regulation 862.1665
1510(k)s in 12 months (162 all time)
0recalls in 12 months (48 all time)
45recalls that name a 510(k)
Top companies in JGS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 1, 2026 | K252475 | ABL90 FLEX PLUS System Radiometer Medicals Aps, DK | JGS |
| Oct 27, 2023 | K230275 | i-STAT CG8+ cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | JGS |
| Jul 25, 2023 | K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl) Siemens Healthcare Diagnostics, Inc. | JGS |
| Jul 20, 2023 | K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd., CN | JGS |
| Mar 10, 2022 | K213486 | GLP systems Track Abbott Laboratories | JGS |
| Apr 14, 2020 | K200403 | Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation | JGS |
| Feb 7, 2020 | K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | JGS |
| Jul 19, 2019 | K191365 | Stat Profile Prime ES Comp Plus Analyzer System Nova Biomedical Corporation | JGS |
| Jun 12, 2019 | K172232 | LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 Ams Diagnostics | JGS |
| Feb 16, 2019 | K183549 | GEM Premier ChemSTAT Instrumentation Laboratory CO | JGS |
| Aug 15, 2018 | K180428 | Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation | JGS |
| Jul 10, 2018 | K181201 | Synermed ISE Reagents Infrared Laboratory Systems, LLC (Dba Synermed) | JGS |
| Feb 27, 2018 | K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) Awareness Technology, Inc. | JGS |
| Mar 9, 2017 | K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica Siemens Healthcare Diagnostics | JGS |
| Dec 16, 2016 | K161837 | ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer Beckman Coulter, Inc. | JGS |
| Dec 14, 2016 | K160225 | GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluat Instrumentation Laboratory CO | JGS |
| Jul 8, 2016 | K153357 | i-STAT Alinity System with i-STAT Sodium test Abbott Point of Care, Inc. | JGS |
| Jun 9, 2016 | K160370 | BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | JGS |
| Dec 11, 2015 | K151767 | Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Br Siemens Healthcare Diagnostics, Inc. | JGS |
| May 22, 2014 | K140373 | ISE INDIRECT NA, K, C1 FOR GEN 2 Roche Diagnostics | JGS |
| Dec 18, 2013 | K132418 | COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 Roche Diagnostics | JGS |
| May 21, 2013 | K123726 | COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 Roche Diagnostics | JGS |
| Aug 22, 2012 | K121140 | PROLYTE ELECTROLYTE ANALYZER Diamond Diagnostics, Inc. | JGS |
| Mar 24, 2011 | K102647 | ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... Elitechgroup Vital Scientific BV | JGS |
| Jan 14, 2011 | K102959 | PROLYTE ELECTROLYTE ANALYZER Diamond Diagnostics, Inc. | JGS |
| Jan 14, 2011 | K100829 | EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520 Medica Corp. | JGS |
| Apr 6, 2010 | K100673 | EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020 Medica Corp. | JGS |
| Sep 3, 2009 | K091861 | VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927 Ortho-Clinical Diagnostics, Inc. | JGS |
| Feb 6, 2009 | K082462 | GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ Diamond Diagnostics, Inc. | JGS |
| Jun 30, 2008 | K081411 | VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 Ortho-Clinical Diagnostics, Inc. | JGS |
| May 7, 2008 | K070104 | PROLYTE ELECTROLYTE ANALYZER Diamond Diagnostics, Inc. | JGS |
| Sep 27, 2006 | K061597 | EPOC BLOOD ANALYSIS SYSTEM Epocal, Inc., CA | JGS |
| Jan 13, 2006 | K053110 | Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbot I-Stat Corporation | JGS |
| Dec 14, 2005 | K053165 | ISE INDIRECT NA, K, CL FOR GEN.2 Roche Diagnostics Corp. | JGS |
| Dec 14, 2005 | K052724 | TECO ISE REAGENT SET FOR CX SYSTEM Teco Diagnostics | JGS |
| Oct 7, 2005 | K051646 | ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH Pointe Scientific, Inc., | JGS |
| Dec 27, 2004 | K040977 | GENCHEM ELECTROLYTE BUFFER Genchem, Inc. | JGS |
| Dec 22, 2004 | K040971 | GENCHEM ISE ELECTROLYTE REFERENCE Genchem, Inc. | JGS |
| Oct 4, 2002 | K023049 | SYNCHRON LX I 725 CLINICAL SYSTEM Beckman Coulter, Inc. | JGS |
| Jun 4, 2002 | K020364 | PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS Phoenix Diagnostics, Inc. | JGS |
| May 16, 2001 | K011213 | MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM Beckman Coulter, Inc. | JGS |
| Feb 2, 2001 | K002407 | EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER Medica Corp. | JGS |
| Oct 12, 2000 | K002855 | BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER Biocare Corp. | JGS |
| Aug 7, 2000 | K001761 | STATLYTE NA/K/CL/LI ANALYZER Nova Biomedical Corp. | JGS |
| Apr 18, 2000 | K001154 | I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER I-Stat Corp. | JGS |
| Apr 17, 2000 | K000895 | STAT PROFILE PHOX PLUS ANALYZER Nova Biomedical Corp. | JGS |
| Nov 26, 1999 | K992844 | HICHEM ISE ELECTROLYTE BUFFER Elan Holdings, Inc. | JGS |
| Nov 26, 1999 | K992842 | HICHEM ISE ELECTROLYTE REFERENCE Elan Holdings, Inc. | JGS |
| Oct 25, 1999 | K993211 | PICCOLO SODIUM TEST SYSTEM Abaxis, Inc. | JGS |
| May 21, 1999 | K990346 | BAYER ADVIA 1650 CHEMISTRY SYSTEM Bayer Corp. | JGS |
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