ClearanceBrief
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)
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Top companies in CEM

DateFirm and productCodeLinked 510(k)
Feb 13, 2026Medica Corporation
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Open, Classified
CEMK021515
Nov 26, 2025Inpeco S.A.
FlexLab (FLX); Version: FLX-217-40;
Open, Classified
CEMK121012
Nov 26, 2025Inpeco S.A.
FlexLab (FLX); Version: FLX-217-10;
Open, Classified
CEMK121012
Oct 9, 2025Inpeco S.A.
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
Open, Classified
CEMK121012
Oct 9, 2025Inpeco S.A.
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Open, Classified
CEMK121012
Dec 15, 2023Inpeco 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
CEMK121012
Oct 31, 2023Randox Laboratories Ltd.
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
Open, Classified
CEMK052914
May 4, 2023Inpeco 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
CEMK121012
May 4, 2023Inpeco 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
CEMK121012
May 4, 2023Inpeco 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
CEMK121012
May 4, 2023Inpeco 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
CEMK121012
May 4, 2023Inpeco 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
CEMK121012
Sep 10, 2021Inpeco S.A.
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Open, Classified
CEMK121012
Apr 28, 2021Randox Laboratories Ltd.
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Terminated
CEMNone listed
Apr 14, 2021Radiometer Medical ApS
E3800 PC Units (spare parts)
Open, Classified
CEMK092686
K160153
Apr 14, 2021Radiometer Medical ApS
Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Open, Classified
CEMK092686
Aug 7, 2020Inpeco 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
CEMK121012
Aug 7, 2020Inpeco 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
CEMK121012
Aug 7, 2020Inpeco 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
CEMK121012
Jul 14, 2020Inpeco 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
CEMK121012
Jul 14, 2020Inpeco 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
CEMK121012
Jul 14, 2020Inpeco 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
CEMK121012
Jun 3, 2020Abbott 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
CEMK093318
Apr 7, 2020Inpeco 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
CEMK121012
Apr 7, 2020Inpeco 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
CEMK121012
Apr 7, 2020Inpeco 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
CEMK121012
Apr 7, 2020Inpeco 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
CEMK121012
Apr 7, 2020Inpeco 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
CEMK121012
Apr 7, 2020Inpeco 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
CEMK121012
Feb 3, 2020Radiometer 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
CEMK092686
Sep 10, 2019Ortho-Clinical Diagnostics
VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
Terminated
CEMK073157
Aug 22, 2019Radiometer America Inc
ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
Terminated
CEMK092686
May 3, 2018Roche 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
CEMK032311
May 3, 2018Roche 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
CEMK032311
May 3, 2018Roche 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
CEMK032311
May 3, 2018Roche 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
CEMK032311
Oct 4, 2016Inpeco 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
CEMK121012
Jun 27, 2015Abbott Laboratories
ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
Terminated
CEMK980367
Apr 7, 2015Siemens 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
CEMK970330
Aug 10, 2013Beckman 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
CEMK965240
Jun 27, 2013Ortho-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
CEMK083680
Nov 19, 2012Beckman 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
CEMK042291
Jul 21, 2011Instrumentation 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
CEMK061974
K093623
Jul 21, 2011Instrumentation 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
CEMK061974
K093623
Jul 21, 2011Instrumentation 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
CEMK093623
Jul 21, 2011Instrumentation 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
CEMK061974
K093623
Apr 28, 2011Radiometer 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
CEMK092686
Apr 26, 2011Beckman 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
CEMK042291
Apr 26, 2011Beckman 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
CEMK042291
Apr 26, 2011Beckman 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
CEMK042291

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