| K230275 | abbott point of care | i-STAT CG8+ cartridge with the i-STAT 1 System | October 27, 2023 |
| K222438 | siemens healthcare diagnostics | A-LYTE® Integrated Multisensor (IMT Na K Cl) | July 25, 2023 |
| K220977 | beckman coulter laboratory systems (suzhou) co | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer | July 20, 2023 |
| K213486 | abbott laboratories | GLP systems Track | March 10, 2022 |
| K200403 | nova biomedical corporation | Stat Profile Prime Plus Analyzer System | April 14, 2020 |
| K183688 | abbott point of care | i-STAT CHEM8+ cartridge with the i-STAT 1 System | February 7, 2020 |
| K191365 | nova biomedical corporation | Stat Profile Prime ES Comp Plus Analyzer System | July 19, 2019 |
| K172232 | ams diagnostics | LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS | June 12, 2019 |
| K183549 | instrumentation laboratory | GEM Premier ChemSTAT | February 16, 2019 |
| K180428 | nova biomedical corporation | Stat Profile Prime Plus Analyzer System | August 15, 2018 |
| K181201 | infrared laboratory systems, llc (dba synermed) | Synermed ISE Reagents | July 10, 2018 |
| K171476 | awareness technology | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) | February 27, 2018 |
| K161954 | siemens healthcare diagnostics | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica C | March 9, 2017 |
| K161837 | beckman coulter | ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer | December 16, 2016 |
| K160225 | instrumentation laboratory | GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calci | December 14, 2016 |
| K153357 | abbott point of care | i-STAT Alinity System with i-STAT Sodium test | July 8, 2016 |
| K160370 | shenzhen mindray bio-medical electronics co | BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry A | June 9, 2016 |
| K151767 | siemens healthcare diagnostics | Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Stan | December 11, 2015 |
| K140373 | roche diagnostics | ISE INDIRECT NA, K, C1 FOR GEN 2 | May 22, 2014 |
| K132418 | roche diagnostics | COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 | December 18, 2013 |