JGS
PROLYTE ELECTROLYTE ANALYZER
- Advisory panel
- Clinical Chemistry
- Total cleared
- 161
Adverse events under product code JGS
product code JGS- Malfunction
- 535
- Total
- 535
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code JGS
1–100 of 161- K230275 — i-STAT CG8+ cartridge with the i-STAT 1 System
- K222438 — A-LYTE® Integrated Multisensor (IMT Na K Cl)
- K220977 — ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
- K213486 — GLP systems Track
- K200403 — Stat Profile Prime Plus Analyzer System
- K183688 — i-STAT CHEM8+ cartridge with the i-STAT 1 System
- K191365 — Stat Profile Prime ES Comp Plus Analyzer System
- K172232 — LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600
- K183549 — GEM Premier ChemSTAT
- K180428 — Stat Profile Prime Plus Analyzer System
- K181201 — Synermed ISE Reagents
- K171476 — SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
- K161954 — 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)
- K161837 — ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
- K160225 — GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator
- K153357 — i-STAT Alinity System with i-STAT Sodium test
- K160370 — BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer
- K151767 — 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
- K140373 — ISE INDIRECT NA, K, C1 FOR GEN 2
- K132418 — COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2
- K123726 — COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2
- K121140 — PROLYTE ELECTROLYTE ANALYZER
- K102647 — ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...
- K100829 — EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520
- K102959 — PROLYTE ELECTROLYTE ANALYZER
- K100673 — EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
- K091861 — VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927
- K082462 — GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+
- K081411 — VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
- K070104 — PROLYTE ELECTROLYTE ANALYZER
- K061597 — EPOC BLOOD ANALYSIS SYSTEM
- K053110 — Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge
- K052724 — TECO ISE REAGENT SET FOR CX SYSTEM
- K053165 — ISE INDIRECT NA, K, CL FOR GEN.2
- K051646 — ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
- K040977 — GENCHEM ELECTROLYTE BUFFER
- K040971 — GENCHEM ISE ELECTROLYTE REFERENCE
- K023049 — SYNCHRON LX I 725 CLINICAL SYSTEM
- K020364 — PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS
- K011213 — MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
- K002407 — EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER
- K002855 — BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER
- K001761 — STATLYTE NA/K/CL/LI ANALYZER
- K001154 — I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER
- K000895 — STAT PROFILE PHOX PLUS ANALYZER
- K992842 — HICHEM ISE ELECTROLYTE REFERENCE
- K992844 — HICHEM ISE ELECTROLYTE BUFFER
- K993211 — PICCOLO SODIUM TEST SYSTEM
- K990346 — BAYER ADVIA 1650 CHEMISTRY SYSTEM
- K990036 — CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000
- K963763 — EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER
- K962334 — EML105 ELECTROLYTE METABOLITE ANALYZER
- K963627 — (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE
- K963542 — SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT
- K961099 — EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)
- K955374 — EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER
- K955375 — EASYSTAT SODIUM/POTASSIUM ANALYZER
- K952179 — SYNERMED ISE REAGENTS
- K935120 — EML 100
- K941400 — SYNERMED ISE REAGENTS
- K940194 — SYNERMED ISE REAGENTS
- K932179 — MODEL 400/450 ELECTROLYTE ANALYZER
- K933862 — ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)
- K933373 — CIBA CORNING 300 SERIES SYSTEM
- K925612 — HI CHEM ELECTROLYTE BUFFER
- K925611 — HI CHEM ELECTROLYTE REFERENCE REAGENT
- K924547 — NOVA 8 CRT ANALYZER
- K924471 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL)
- K923806 — ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER
- K921937 — NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATION
- K921718 — OLYMPUS ISE MODULE
- K922215 — NOVA 14 NA/K/CL/GLU/BUN ANALYZER
- K915176 — NOVA 4 NA/K/C1/TCO2/LI ANALYZER
- K914810 — EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER
- K903564 — MEDISENSOR 2001
- K912560 — NOVA 12 ANALYZER
- K912648 — ISE/NA+
- K912387 — I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK
- K912559 — NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZER
- K912016 — IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER
- K910305 — GEM-PREMIER SYSTEM
- K910554 — CLINAK(TM) ISE SUBSYSTEM
- K905264 — STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS
- K905600 — TECHLYTE ELECTROLYTE ANALYZER
- K904335 — SECONDARY CALIBRATORS
- K903188 — ABBOTT VISION LYTE (TM) SODIUM
- K901042 — IONOMETER EF-HK AND ACCESSORIES
- K901040 — IONOMETER EH-F AND ACCESSORIES
- K896526 — LYTENING(TM) 5, LYTENING(TM) SYSTEM 30
- K895936 — EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER
- K894035 — EOS CHEMISTRY ANALYZER
- K895672 — TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD
- K894914 — MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK
- K894218 — NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM
- K892500 — CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE
- K882801 — RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN.
- K882104 — ION SELECTIVE ELECTRODE SUBSYSTEM OF PARA. ANALYT.
- K880750 — NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT
- K880917 — LYTENING 5
- K881255 — NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA
Data sourced from openFDA. This site is unofficial and independent of the FDA.