| ABL90 FLEX PLUS System (K252475) | Radiometer Medicals Aps | 2026-05-01 |
| i-STAT CG8+ cartridge with the i-STAT 1 System (K230275) | Abbott Point of Care, Inc. | 2023-10-27 |
| A-LYTE® Integrated Multisensor (IMT Na K Cl) (K222438) | Siemens Healthcare Diagnostics, Inc. | 2023-07-25 |
| ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer (K220977) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | 2023-07-20 |
| GLP systems Track (K213486) | Abbott Laboratories | 2022-03-10 |
| Stat Profile Prime Plus Analyzer System (K200403) | Nova Biomedical Corporation | 2020-04-14 |
| i-STAT CHEM8+ cartridge with the i-STAT 1 System (K183688) | Abbott Point of Care, Inc. | 2020-02-07 |
| Stat Profile Prime ES Comp Plus Analyzer System (K191365) | Nova Biomedical Corporation | 2019-07-19 |
| LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 (K172232) | Ams Diagnostics | 2019-06-12 |
| GEM Premier ChemSTAT (K183549) | Instrumentation Laboratory CO | 2019-02-16 |
| Stat Profile Prime Plus Analyzer System (K180428) | Nova Biomedical Corporation | 2018-08-15 |
| Synermed ISE Reagents (K181201) | Infrared Laboratory Systems, LLC (Dba Synermed) | 2018-07-10 |
| SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) (K171476) | Awareness Technology, Inc. | 2018-02-27 |
| 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) (K161954) | Siemens Healthcare Diagnostics | 2017-03-09 |
| ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer (K161837) | Beckman Coulter, Inc. | 2016-12-16 |
| GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator (K160225) | Instrumentation Laboratory CO | 2016-12-14 |
| i-STAT Alinity System with i-STAT Sodium test (K153357) | Abbott Point of Care, Inc. | 2016-07-08 |
| BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer (K160370) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016-06-09 |
| 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 (K151767) | Siemens Healthcare Diagnostics, Inc. | 2015-12-11 |
| ISE INDIRECT NA, K, C1 FOR GEN 2 (K140373) | Roche Diagnostics | 2014-05-22 |
| COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 (K132418) | Roche Diagnostics | 2013-12-18 |
| COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 (K123726) | Roche Diagnostics | 2013-05-21 |
| PROLYTE ELECTROLYTE ANALYZER (K121140) | Diamond Diagnostics, Inc. | 2012-08-22 |
| ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... (K102647) | Elitechgroup Vital Scientific BV | 2011-03-24 |
| PROLYTE ELECTROLYTE ANALYZER (K102959) | Diamond Diagnostics, Inc. | 2011-01-14 |
| EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520 (K100829) | Medica Corp. | 2011-01-14 |
| EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020 (K100673) | Medica Corp. | 2010-04-06 |
| VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927 (K091861) | Ortho-Clinical Diagnostics, Inc. | 2009-09-03 |
| GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ (K082462) | Diamond Diagnostics, Inc. | 2009-02-06 |
| VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 (K081411) | Ortho-Clinical Diagnostics, Inc. | 2008-06-30 |
| PROLYTE ELECTROLYTE ANALYZER (K070104) | Diamond Diagnostics, Inc. | 2008-05-07 |
| EPOC BLOOD ANALYSIS SYSTEM (K061597) | Epocal, Inc. | 2006-09-27 |
| 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 (K053110) | I-Stat Corporation | 2006-01-13 |
| ISE INDIRECT NA, K, CL FOR GEN.2 (K053165) | Roche Diagnostics Corp. | 2005-12-14 |
| TECO ISE REAGENT SET FOR CX SYSTEM (K052724) | Teco Diagnostics | 2005-12-14 |
| ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH (K051646) | Pointe Scientific, Inc., | 2005-10-07 |
| GENCHEM ELECTROLYTE BUFFER (K040977) | Genchem, Inc. | 2004-12-27 |
| GENCHEM ISE ELECTROLYTE REFERENCE (K040971) | Genchem, Inc. | 2004-12-22 |
| SYNCHRON LX I 725 CLINICAL SYSTEM (K023049) | Beckman Coulter, Inc. | 2002-10-04 |
| PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS (K020364) | Phoenix Diagnostics, Inc. | 2002-06-04 |
| MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM (K011213) | Beckman Coulter, Inc. | 2001-05-16 |
| EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER (K002407) | Medica Corp. | 2001-02-02 |
| BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER (K002855) | Biocare Corp. | 2000-10-12 |
| STATLYTE NA/K/CL/LI ANALYZER (K001761) | Nova Biomedical Corp. | 2000-08-07 |
| I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER (K001154) | I-Stat Corp. | 2000-04-18 |
| STAT PROFILE PHOX PLUS ANALYZER (K000895) | Nova Biomedical Corp. | 2000-04-17 |
| HICHEM ISE ELECTROLYTE REFERENCE (K992842) | Elan Holdings, Inc. | 1999-11-26 |
| HICHEM ISE ELECTROLYTE BUFFER (K992844) | Elan Holdings, Inc. | 1999-11-26 |
| PICCOLO SODIUM TEST SYSTEM (K993211) | Abaxis, Inc. | 1999-10-25 |
| BAYER ADVIA 1650 CHEMISTRY SYSTEM (K990346) | Bayer Corp. | 1999-05-21 |
| CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 (K990036) | Careside, Inc. | 1999-03-18 |
| EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER (K963763) | Medica Corp. | 1996-11-29 |
| EML105 ELECTROLYTE METABOLITE ANALYZER (K962334) | Radiometer America, Inc. | 1996-10-24 |
| (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE (K963627) | Roche Diagnostic Systems, Inc. | 1996-10-24 |
| SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT (K963542) | Sigma Diagnostics, Inc. | 1996-09-27 |
| EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+) (K961099) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-07 |
| EASYSTAT SODIUM/POTASSIUM ANALYZER (K955375) | Medica Corp. | 1996-02-23 |
| EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER (K955374) | Medica Corp. | 1996-02-23 |
| SYNERMED ISE REAGENTS (K952179) | Synermed, Inc. | 1995-06-20 |
| SYNERMED ISE REAGENTS (K941400) | Synermed, Inc. | 1994-04-26 |
| EML 100 (K935120) | Radiometer America, Inc. | 1994-04-26 |
| SYNERMED ISE REAGENTS (K940194) | Synermed, Inc. | 1994-04-05 |
| MODEL 400/450 ELECTROLYTE ANALYZER (K932179) | Ionetics, Inc. | 1993-11-17 |
| ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE) (K933862) | Schiapparelli Biosystems, Inc. | 1993-10-12 |
| CIBA CORNING 300 SERIES SYSTEM (K933373) | Ciba Corning Diagnostics Corp. | 1993-08-19 |
| HI CHEM ELECTROLYTE BUFFER (K925612) | Hichem Diagnostics | 1993-04-20 |
| HI CHEM ELECTROLYTE REFERENCE REAGENT (K925611) | Hichem Diagnostics | 1993-02-23 |
| NOVA 8 CRT ANALYZER (K924547) | Nova Biomedical Corp. | 1993-01-28 |
| KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL) (K924471) | Eastman Kodak Company | 1992-11-06 |
| ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER (K923806) | Nova Biomedical Corp. | 1992-09-29 |
| NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATION (K921937) | Nova Biomedical Corp. | 1992-07-27 |
| OLYMPUS ISE MODULE (K921718) | Olympus Corp. | 1992-07-21 |
| NOVA 14 NA/K/CL/GLU/BUN ANALYZER (K922215) | Nova Biomedical Corp. | 1992-07-17 |
| NOVA 4 NA/K/C1/TCO2/LI ANALYZER (K915176) | Nova Biomedical Corp. | 1992-01-15 |
| EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER (K914810) | Medica Corp. | 1991-12-04 |
| MEDISENSOR 2001 (K903564) | Medtest Systems, Inc. | 1991-09-30 |
| NOVA 12 ANALYZER (K912560) | Nova Biomedical Corp. | 1991-07-17 |
| ISE/NA+ (K912648) | Boehringer Mannheim Corp. | 1991-07-17 |
| NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZER (K912559) | Nova Biomedical Corp. | 1991-07-01 |
| I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK (K912387) | I-Stat Corp. | 1991-07-01 |
| IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER (K912016) | Instrumentation Laboratory CO | 1991-06-10 |
| GEM-PREMIER SYSTEM (K910305) | Mallinckrodt Sensor Systems, Inc. | 1991-04-03 |
| CLINAK(TM) ISE SUBSYSTEM (K910554) | Baxter Healthcare Corp | 1991-03-06 |
| STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS (K905264) | Nova Biomedical Corp. | 1991-03-05 |
| TECHLYTE ELECTROLYTE ANALYZER (K905600) | Technalysis, Inc. | 1991-01-15 |
| SECONDARY CALIBRATORS (K904335) | Bionostics, Inc. | 1990-10-12 |
| ABBOTT VISION LYTE (TM) SODIUM (K903188) | Abbott Laboratories | 1990-09-10 |
| IONOMETER EF-HK AND ACCESSORIES (K901042) | Fresenius USA, Inc. | 1990-07-31 |
| IONOMETER EH-F AND ACCESSORIES (K901040) | Fresenius USA, Inc. | 1990-07-19 |
| LYTENING(TM) 5, LYTENING(TM) SYSTEM 30 (K896526) | Baxter Healthcare Corp | 1990-01-02 |
| EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER (K895936) | Medica Corp. | 1989-12-12 |
| EOS CHEMISTRY ANALYZER (K894035) | Eos Technology Corp. | 1989-10-31 |
| TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD (K895672) | Technicon Instruments Corp. | 1989-10-25 |
| MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK (K894914) | I-Stat Corp. | 1989-10-16 |
| NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM (K894218) | Nova Biomedical Corp. | 1989-09-07 |
| CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE (K892500) | Ciba Corning Diagnostics Corp. | 1989-07-20 |
| RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN. (K882801) | Hf Scientific, Inc. | 1988-08-29 |
| ION SELECTIVE ELECTRODE SUBSYSTEM OF PARA. ANALYT. (K882104) | Paramax Systems Div. Baxter Healthcare | 1988-07-05 |
| NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT (K880750) | Nova Biomedical Corp. | 1988-07-01 |
| LYTENING 5 (K880917) | Amdev, Inc. | 1988-05-27 |