CEM · Electrode, Ion Specific, Potassium
Clinical Chemistry · 21 CFR 862.1600 · Class 2
Overview
| Product Code | CEM |
|---|---|
| Device Name | Electrode, Ion Specific, Potassium |
| Regulation | 21 CFR 862.1600 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 89)
Showing 20 most recent of 89 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions | Roche Diagnostics | Feb 12, 2026 | SESE |
| K241037 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | Jan 14, 2025 | SESE |
| K220396 | EasyStat 300 | Medica Corporation | Sep 26, 2023 | SESE |
| K230890 | ISE Electrodes | Randox Laboratories, Ltd. | Sep 8, 2023 | SESE |
| K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ | Diamond Diagnostics, Inc. | Oct 1, 2020 | SESE |
| K121012 | FLEXLAB 3.6, ACCELERATOR A3600 | Inpeco S.P.A. | Aug 31, 2012 | SESE |
| K121040 | SMARTLYTE ELECTROLYTE ANALYZER | Diamond Diagnostics, Inc. | Aug 30, 2012 | SESE |
| K112995 | GEM PREMIER 4000 | Instrumentation Laboratory CO | May 3, 2012 | SESE |
| K110520 | BIOLIS 12I | Tokyo Boeki Medisys, Inc. | Mar 23, 2012 | SESE |
| K112412 | AU5800(R) CHEMISTRY ANALYZER | Beckman Coulter, Inc. | Dec 23, 2011 | SESE |
| K112408 | POLY-CHEM 90 ISE MODULE | Polymedco, Inc. | Nov 4, 2011 | SESE |
| K112788 | EASTLYTE NA/K/CA/PH | Medica Corp. | Oct 20, 2011 | SESE |
| K092686 | ABL90 FLEX SERIES | Radiometer Medical Aps | Aug 6, 2010 | SESE |
| K092849 | BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER | Epocal, Inc. | Mar 30, 2010 | SESE |
| K093318 | ACCELERATOR APS | Abbott Laboratories | Feb 19, 2010 | SESE |
| K083680 | VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 | Ortho-Clinical Diagnostics, Inc. | Feb 27, 2009 | SESE |
| K073157 | VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 | Ortho-Clinical Diagnostics, Inc. | Dec 7, 2007 | SESE |
| K061107 | DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 | Thermo Electron OY | Aug 8, 2006 | SESE |
| K061730 | OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 | Osmetech, Inc. | Aug 4, 2006 | SESE |
| K052914 | RX IMOLA | Randox Laboratories, Ltd. | Mar 31, 2006 | SESE |
Top Applicants
- Abbott Laboratories — 4 clearances
- Nova Biomedical Corp. — 4 clearances
- Avl Scientific Corp. — 3 clearances
- Boehringer Mannheim Corp. — 3 clearances
- Hi Chem, Inc. — 3 clearances
