CEM — Electrode, Ion Specific, Potassium Class II
FDA product code CEM covers "Electrode, Ion Specific, Potassium", a Class II medical device regulated under 21 CFR 862.1600. 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
- 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 |