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
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2026 | Medica Corporation Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit. Open, Classified |
CEM | K021515 |
| Nov 26, 2025 | Inpeco S.A. FlexLab (FLX);
Version: FLX-217-40; Open, Classified |
CEM | K121012 |
| Nov 26, 2025 | Inpeco S.A. FlexLab (FLX);
Version: FLX-217-10; Open, Classified |
CEM | K121012 |
| Oct 9, 2025 | Inpeco S.A. FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic Open, Classified |
CEM | K121012 |
| Oct 9, 2025 | Inpeco S.A. FlexLab (FLX) System. Potassium Test System. in vitro diagnostic Open, Classified |
CEM | K121012 |
| Dec 15, 2023 | Inpeco S.A. Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order t Open, Classified |
CEM | K121012 |
| Oct 31, 2023 | Randox Laboratories Ltd. RX Imola-IVD Clinical Chemistry Analyzer
Catalog Number: RX4900. RX4900R (refurbished) Open, Classified |
CEM | K052914 |
| May 4, 2023 | Inpeco S.A. Alinity h Interface Module (HSQ)-Laboratory Automation system
Brand names of the same product: FlexLab (FLX), Accelerator
a3600 (ACP), Aptio Automation (AP2)
Part Numbers: FLX-274-20 Open, Classified |
CEM | K121012 |
| May 4, 2023 | Inpeco S.A. Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system
Brand names of the same product: FlexLab (FLX), Accelerator
a3600 (ACP), Aptio Automation (AP2)
Part Numbers: 72747000.A Open, Classified |
CEM | K121012 |
| May 4, 2023 | Inpeco S.A. PVT Interface Module (PVT)-Laboratory Automation system
Brand names of the same product: FlexLab (FLX), Accelerator
a3600 (ACP), Aptio Automation (AP2)
Part Numbers: 72747000.A Open, Classified |
CEM | K121012 |
| May 4, 2023 | Inpeco S.A. Storage and Retrieval Module (SRM)-Laboratory Automation system
Brand names of the same product: FlexLab (FLX), Accelerator
a3600 (ACP), Aptio Automation (AP2)
Part Numbers:
ACP-207-00, ACP-207-01, Open, Classified |
CEM | K121012 |
| May 4, 2023 | Inpeco S.A. Input Output Module (IOM) FLX-201-Laboratory Automation system
Brand names of the same product: FlexLab (FLX), Accelerator
a3600 (ACP), Aptio Automation (AP2)
Part Numbers:
FLX-201-00,
APT-201-00, Open, Classified |
CEM | K121012 |
| Sep 10, 2021 | Inpeco S.A. FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.) Open, Classified |
CEM | K121012 |
| Apr 28, 2021 | Randox Laboratories Ltd. Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R Terminated |
CEM | None listed |
| Apr 14, 2021 | Radiometer Medical ApS E3800 PC Units (spare parts) Open, Classified |
CEM | K092686 K160153 |
| Apr 14, 2021 | Radiometer Medical ApS Radiometer ABL90 FLEX Analyzer with E3800 PC units.
The E3800 CPU is also used as spare part. Open, Classified |
CEM | K092686 |
| Aug 7, 2020 | Inpeco S.A. Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: Terminated |
CEM | K121012 |
| Aug 7, 2020 | Inpeco S.A. Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: Terminated |
CEM | K121012 |
| Aug 7, 2020 | Inpeco S.A. FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and
Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Product Usage: The FlexLab Terminated |
CEM | K121012 |
| Jul 14, 2020 | Inpeco S.A. Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212)
The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analy Terminated |
CEM | K121012 |
| Jul 14, 2020 | Inpeco S.A. Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212)
The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical an Terminated |
CEM | K121012 |
| Jul 14, 2020 | Inpeco S.A. FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212)
The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Pos Terminated |
CEM | K121012 |
| Jun 3, 2020 | Abbott Laboratories Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. T Terminated |
CEM | K093318 |
| Apr 7, 2020 | Inpeco S.A. FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rac Terminated |
CEM | K121012 |
| Apr 7, 2020 | Inpeco S.A. Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation. Open, Classified |
CEM | K121012 |
| Apr 7, 2020 | Inpeco S.A. Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation. Open, Classified |
CEM | K121012 |
| Apr 7, 2020 | Inpeco S.A. FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation. Open, Classified |
CEM | K121012 |
| Apr 7, 2020 | Inpeco S.A. Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-An Terminated |
CEM | K121012 |
| Apr 7, 2020 | Inpeco S.A. Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre- Terminated |
CEM | K121012 |
| Feb 3, 2020 | Radiometer Medical ApS ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. Terminated |
CEM | K092686 |
| Sep 10, 2019 | Ortho-Clinical Diagnostics VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form. Terminated |
CEM | K073157 |
| Aug 22, 2019 | Radiometer America Inc ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 Terminated |
CEM | K092686 |
| May 3, 2018 | Roche Diagnostics Corporation cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measuremen Terminated |
CEM | K032311 |
| May 3, 2018 | Roche Diagnostics Corporation cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measureme Terminated |
CEM | K032311 |
| May 3, 2018 | Roche Diagnostics Corporation Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurem Terminated |
CEM | K032311 |
| May 3, 2018 | Roche Diagnostics Corporation cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measuremen Terminated |
CEM | K032311 |
| Oct 4, 2016 | Inpeco S.A. FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the La Terminated |
CEM | K121012 |
| Jun 27, 2015 | Abbott Laboratories ICT Serum Calibrator REF 146-03.
For use in the calibration of the serum Sodium, Potassium, and Chloride assays. Terminated |
CEM | K980367 |
| Apr 7, 2015 | Siemens Healthcare Diagnostics, Inc. QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module.
Intended Use of the QuikLYTE module : The Na+, K+, Cl and Terminated |
CEM | K970330 |
| Aug 10, 2013 | Beckman Coulter Inc. ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915.
Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Terminated |
CEM | K965240 |
| Jun 27, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596,
Product Usage:
For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure po Terminated |
CEM | K083680 |
| Nov 19, 2012 | Beckman Coulter Inc. UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102.
The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, s Terminated |
CEM | K042291 |
| Jul 21, 2011 | Instrumentation Laboratory Co. GEM PREMIER 4000 CARTRIDGE K+ REPORTING:
GEM 4000 BG/Hct/Lytes/G/L/CO-Ox/tBili :
75 test iQM Part Number:00027407511
150 test iQM Part Number: 00027415011
300 test iQM Part Number: 00027430011
4 Terminated |
CEM | K061974 K093623 |
| Jul 21, 2011 | Instrumentation Laboratory Co. GEM PREMIER 4000 CARTRIDGE K+ REPORTING:
GEM 4000 BG/Hct/Lytes/CO-Ox/tBili
75 test iQM Part Number: 00027407509
150 test iQM Part Number: 00027415009
300 test iQM Part Number: 00027430009
450 t Terminated |
CEM | K061974 K093623 |
| Jul 21, 2011 | Instrumentation Laboratory Co. GEM PREMIER 4000 CARTRIDGE K+ REPORTING:
GEM 4000 BG/Hct/Lytes/G/L/CO-Ox
75 test iQM Part Number : 00027407510
150 test iQM Part Number:00027415010
300 test iQM Part Number: 00027430010
450 test Terminated |
CEM | K093623 |
| Jul 21, 2011 | Instrumentation Laboratory Co. GEM PREMIER 4000 CARTRIDGE K+ REPORTING:
GEM 4000 BG/Hct/Lytes/CO-Ox
75 test iQM Part Number: 00027407508
150 test iQM Part Number: 00027415008
300 test iQM Part Number : 00027430008
450 tes Terminated |
CEM | K061974 K093623 |
| Apr 28, 2011 | Radiometer America Inc ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall.
The Terminated |
CEM | K092686 |
| Apr 26, 2011 | Beckman Coulter Inc. UniCel DxC 600
The UniCel DxC SynchronClinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistrie Terminated |
CEM | K042291 |
| Apr 26, 2011 | Beckman Coulter Inc. UniCel 600 PRO
The UniCel DxC SynchronClinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistrie Terminated |
CEM | K042291 |
| Apr 26, 2011 | Beckman Coulter Inc. UniCel DxC 600i
The UniCel DxC SynchronClinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistri Terminated |
CEM | K042291 |
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