CEM — Electrode, Ion Specific, Potassium Class II
FDA Device Classification
Classification Details
- Product Code
- CEM
- Device Class
- Class II
- Regulation Number
- 862.1600
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253491 | roche diagnostics | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; | February 12, 2026 |
| K241037 | radiometer medicals aps | ABL90 FLEX PLUS System | January 14, 2025 |
| K220396 | medica corporation | EasyStat 300 | September 26, 2023 |
| K230890 | randox laboratories | ISE Electrodes | September 8, 2023 |
| K200544 | diamond diagnostics | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ | October 1, 2020 |
| K121012 | inpeco | FLEXLAB 3.6, ACCELERATOR A3600 | August 31, 2012 |
| K121040 | diamond diagnostics | SMARTLYTE ELECTROLYTE ANALYZER | August 30, 2012 |
| K112995 | instrumentation laboratory | GEM PREMIER 4000 | May 3, 2012 |
| K110520 | tokyo boeki medisys | BIOLIS 12I | March 23, 2012 |
| K112412 | beckman coulter | AU5800(R) CHEMISTRY ANALYZER | December 23, 2011 |
| K112408 | polymedco | POLY-CHEM 90 ISE MODULE | November 4, 2011 |
| K112788 | medica | EASTLYTE NA/K/CA/PH | October 20, 2011 |
| K092686 | radiometer medical aps | ABL90 FLEX SERIES | August 6, 2010 |
| K092849 | epocal | BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER | March 30, 2010 |
| K093318 | abbott laboratories | ACCELERATOR APS | February 19, 2010 |
| K083680 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR K | February 27, 2009 |
| K073157 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 | December 7, 2007 |
| K061107 | thermo electron | DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 | August 8, 2006 |
| K061730 | osmetech | OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 | August 4, 2006 |
| K052914 | randox laboratories | RX IMOLA | March 31, 2006 |