Panels › Clinical Chemistry › Product code CEM · Class 2
Electrode, Ion Specific, Potassium
Regulation 862.1600
1510(k)s in 12 months (89 all time)
3recalls in 12 months (63 all time)
61recalls that name a 510(k)
Top companies in CEM
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 2026 | 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 | CEM |
| Jan 14, 2025 | K241037 | ABL90 FLEX PLUS System Radiometer Medicals Aps, DK | CEM |
| Sep 26, 2023 | K220396 | EasyStat 300 Medica Corporation | CEM |
| Sep 8, 2023 | K230890 | ISE Electrodes Randox Laboratories, Ltd., GB | CEM |
| Oct 1, 2020 | K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ Diamond Diagnostics, Inc. | CEM |
| Aug 31, 2012 | K121012 | FLEXLAB 3.6, ACCELERATOR A3600 Inpeco S.P.A., IT | CEM |
| Aug 30, 2012 | K121040 | SMARTLYTE ELECTROLYTE ANALYZER Diamond Diagnostics, Inc. | CEM |
| May 3, 2012 | K112995 | GEM PREMIER 4000 Instrumentation Laboratory CO | CEM |
| Mar 23, 2012 | K110520 | BIOLIS 12I Tokyo Boeki Medisys, Inc. | CEM |
| Dec 23, 2011 | K112412 | AU5800(R) CHEMISTRY ANALYZER Beckman Coulter, Inc. | CEM |
| Nov 4, 2011 | K112408 | POLY-CHEM 90 ISE MODULE Polymedco, Inc. | CEM |
| Oct 20, 2011 | K112788 | EASTLYTE NA/K/CA/PH Medica Corp. | CEM |
| Aug 6, 2010 | K092686 | ABL90 FLEX SERIES Radiometer Medical Aps, DK | CEM |
| Mar 30, 2010 | K092849 | BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER Epocal, Inc., CA | CEM |
| Feb 19, 2010 | K093318 | ACCELERATOR APS Abbott Laboratories | CEM |
| Feb 27, 2009 | K083680 | VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 Ortho-Clinical Diagnostics, Inc. | CEM |
| Dec 7, 2007 | K073157 | VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 Ortho-Clinical Diagnostics, Inc. | CEM |
| Aug 8, 2006 | K061107 | DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 Thermo Electron OY, FI | CEM |
| Aug 4, 2006 | K061730 | OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 Osmetech, Inc. | CEM |
| Mar 31, 2006 | K052914 | RX IMOLA Randox Laboratories, Ltd., GB | CEM |
| Mar 13, 2006 | K060373 | COBAS 6000 SERIES SYSTEM Roche Diagnostics | CEM |
| Nov 12, 2004 | K042291 | UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS Beckman Coulter, Inc. | CEM |
| Oct 28, 2004 | K040750 | BIO-CHEM ANALYZER, MODEL 100 Clinical Analysis Corporation, Inc. | CEM |
| Oct 6, 2004 | K042270 | STAT K IN VITRO DIAGNOSTIC TEST SYSTEM Stat Chem, Inc. | CEM |
| Oct 17, 2003 | K032311 | ROCHE DIAGNOSTICS OMNI S ANALYZER Roche Diagnostics Corp. | CEM |
| Nov 2, 2001 | K013373 | OMNI C ANALYZER Roche Diagnostics Corp. | CEM |
| Mar 14, 2001 | K010061 | DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND Dade Behring, Inc. | CEM |
| Oct 5, 1999 | K993083 | ALCYON 300I (WITH ISE MODULE) ANALYZER Abbott Laboratories | CEM |
| Feb 24, 1998 | K974784 | AVL OPTI CRITICAL CARE ANALYZER Avl Scientific Corp. | CEM |
| Apr 14, 1997 | K970330 | DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE Dade Intl., Inc. | CEM |
| Jun 21, 1996 | K961326 | EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER Medica Corp. | CEM |
| May 7, 1996 | K961115 | EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) Johnson & Johnson Clinical Diagnostics, Inc. | CEM |
| Jul 27, 1993 | K932044 | DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD Dupont Medical Products | CEM |
| Oct 13, 1992 | K922943 | NOVA NA/K/CL/LI MODULE Nova Biomedical Corp. | CEM |
| Aug 24, 1992 | K923038 | MILES POTASSIUM METHOD Heraeus Kulzer, Inc. | CEM |
| Jul 16, 1992 | K915345 | STAT K SYSTEM Portable Diagnostic Services, Inc. | CEM |
| Jan 27, 1992 | K915178 | NOVA 11 NA/K/LI ANALYZER Nova Biomedical Corp. | CEM |
| Jan 27, 1992 | K915177 | NOVA 5 NA/K/C1 ALALYZER Nova Biomedical Corp. | CEM |
| Jul 15, 1991 | K912649 | ISE/K+ Boehringer Mannheim Corp. | CEM |
| Jul 5, 1990 | K900788 | MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER Datachem, Inc. | CEM |
| Jun 28, 1990 | K901039 | IONOMETER EH Fresenius USA, Inc. | CEM |
| Jun 18, 1990 | K901041 | IONOMETER EH-HK AND ACCESSORIES Fresenius USA, Inc. | CEM |
| Mar 1, 1990 | K900300 | LYTENING 2Z LYTENING SYSTEM 31 Baxter Healthcare Corp | CEM |
| Feb 27, 1990 | K897110 | SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM Medisense, Inc. | CEM |
| Jan 2, 1990 | K896692 | AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER Baxter Healthcare Corp | CEM |
| Nov 14, 1989 | K895664 | TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD Technicon Instruments Corp. | CEM |
| May 3, 1989 | K890792 | POTASSIUM AND SODIUM ELECTROLYTE ANALYZER Ionetics, Inc. | CEM |
| Jan 17, 1989 | K884769 | MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY Ciba Corning Diagnostics Corp. | CEM |
| Dec 2, 1988 | K884566 | VISION LYTE (TM) POTASSIUM Abbott Laboratories | CEM |
| Sep 22, 1988 | K883240 | AVL MODEL 986 ELECTROLYTE ANALYZER Avl Scientific Corp. | CEM |
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