JGS — Electrode, Ion Specific, Sodium Class II
FDA product code JGS covers "Electrode, Ion Specific, Sodium", a Class II medical device regulated under 21 CFR 862.1665. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JGS
- Device Class
- Class II
- Regulation Number
- 862.1665
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252475 | radiometer medicals aps | ABL90 FLEX PLUS System | May 1, 2026 |
| 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 |