Product code CEM
- Device name
- Electrode, Ion Specific, Potassium
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1600
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 | 2026-02-12 |
| K241037 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2025-01-14 |
| K220396 | EasyStat 300 | Medica Corporation | 2023-09-26 |
| K230890 | ISE Electrodes | Randox Laboratories, Ltd. | 2023-09-08 |
| K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ | Diamond Diagnostics, Inc. | 2020-10-01 |
| K121012 | FLEXLAB 3.6, ACCELERATOR A3600 | Inpeco S.P.A. | 2012-08-31 |
| K121040 | SMARTLYTE ELECTROLYTE ANALYZER | Diamond Diagnostics, Inc. | 2012-08-30 |
| K112995 | GEM PREMIER 4000 | Instrumentation Laboratory CO | 2012-05-03 |
| K110520 | BIOLIS 12I | Tokyo Boeki Medisys, Inc. | 2012-03-23 |
| K112412 | AU5800(R) CHEMISTRY ANALYZER | Beckman Coulter, Inc. | 2011-12-23 |
| K112408 | POLY-CHEM 90 ISE MODULE | Polymedco, Inc. | 2011-11-04 |
| K112788 | EASTLYTE NA/K/CA/PH | Medica Corp. | 2011-10-20 |
| K092686 | ABL90 FLEX SERIES | Radiometer Medical Aps | 2010-08-06 |
| K092849 | BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER | Epocal, Inc. | 2010-03-30 |
| K093318 | ACCELERATOR APS | Abbott Laboratories | 2010-02-19 |
| K083680 | VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 | Ortho-Clinical Diagnostics, Inc. | 2009-02-27 |
| K073157 | VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 | Ortho-Clinical Diagnostics, Inc. | 2007-12-07 |
| K061107 | DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 | Thermo Electron OY | 2006-08-08 |
| K061730 | OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 | Osmetech, Inc. | 2006-08-04 |
| K052914 | RX IMOLA | Randox Laboratories, Ltd. | 2006-03-31 |
| K060373 | COBAS 6000 SERIES SYSTEM | Roche Diagnostics | 2006-03-13 |
| K042291 | UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS | Beckman Coulter, Inc. | 2004-11-12 |
| K040750 | BIO-CHEM ANALYZER, MODEL 100 | Clinical Analysis Corporation, Inc. | 2004-10-28 |
| K042270 | STAT K IN VITRO DIAGNOSTIC TEST SYSTEM | Stat Chem, Inc. | 2004-10-06 |
| K032311 | ROCHE DIAGNOSTICS OMNI S ANALYZER | Roche Diagnostics Corp. | 2003-10-17 |
| K013373 | OMNI C ANALYZER | Roche Diagnostics Corp. | 2001-11-02 |
| K010061 | DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND | Dade Behring, Inc. | 2001-03-14 |
| K993083 | ALCYON 300I (WITH ISE MODULE) ANALYZER | Abbott Laboratories | 1999-10-05 |
| K974784 | AVL OPTI CRITICAL CARE ANALYZER | Avl Scientific Corp. | 1998-02-24 |
| K970330 | DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE | Dade Intl., Inc. | 1997-04-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10054749005519 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-05-01 |
| 08426950807582 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807827 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 450 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807810 | GEM Premier 5000 PAK BG/ISE/GL/COOX 450 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807803 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 450 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807797 | GEM Premier 5000 PAK BG/ISE/COOX 450 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807766 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 300 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807759 | GEM Premier 5000 PAK BG/ISE/GL/COOX 300 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807742 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 300 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807735 | GEM Premier 5000 PAK BG/ISE/COOX 300 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807704 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 150 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807681 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 150 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807674 | GEM Premier 5000 PAK BG/ISE/COOX 150 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807643 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 75 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807636 | GEM Premier 5000 PAK BG/ISE/GL/COOX 75 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807629 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 75 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807612 | GEM Premier 5000 PAK BG/ISE/COOX 75 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807605 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 600 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807599 | GEM Premier 5000 PAK BG/ISE/GL/COOX 600 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807698 | GEM Premier 5000 PAK BG/ISE/GL/COOX 150 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807575 | GEM Premier 5000 PAK BG/ISE/COOX 600 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08430215011539 | Potassium Electrode | Roche Diagnostics GmbH | 2016-09-20 |
| 10054749000163 | i-STAT | ABBOTT POINT OF CARE INC. | 2016-09-09 |
| 00380740000400 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740010324 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740019327 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740019341 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740000363 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740000394 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740003821 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |