CEM

Product Code: CEM


Products Classified as CEM

268Electrode, Ion Specific, PotassiumPotassium Test System.

Total Product Life Cycle (TPLC) Devices

268Electrode, Ion Specific, PotassiumPotassium Test System.

FDA Consensus Standards

Electrode, Ion Specific, Potassium [11427]21 CFR §862.1600 🔎

Pre-market Notifications for CEM

K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics Inc.
K121040SMARTLYTE ELECTROLYTE ANALYZERDIAMOND DIAGNOSTICS, INC.
K121012FLEXLAB 3.6, ACCELERATOR A3600INPECO S.P.A.
K112995GEM PREMIER 4000INSTRUMENTATION LABORATORY CO.
K112788EASTLYTE NA/K/CA/PHMEDICA CORP.
K112408POLY-CHEM 90 ISE MODULEPOLYMEDCO, INC.
K112412AU5800(R) CHEMISTRY ANALYZERBECKMAN COULTER, INC.
K110520BIOLIS 12ITOKYO BOEKI MEDISYS INC.
K093318ACCELERATOR APSABBOTT LABORATORIES
K092849BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZEREPOCAL, INC.
K092686ABL90 FLEX SERIESRADIOMETER MEDICAL APS
K083680VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258Ortho-Clinical Diagnostics, Inc.
K073157VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2Ortho-Clinical Diagnostics, Inc.
K061730OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044OSMETECH, INC.
K061107DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247THERMO ELECTRON OY

Global Unique Device Identification Database

00386100003289Electrode, Ion Specific, Potassium
00386100003272Electrode, Ion Specific, Potassium
00386100003210Electrode, Ion Specific, Potassium
00386100003203Electrode, Ion Specific, Potassium
00386100003197Electrode, Ion Specific, Potassium
00386100003180Electrode, Ion Specific, Potassium
00386100003173Electrode, Ion Specific, Potassium
00386100003081Electrode, Ion Specific, Potassium
00386100003029Electrode, Ion Specific, Potassium
00386100002985Electrode, Ion Specific, Potassium
00386100002961Electrode, Ion Specific, Potassium
00386100002862Electrode, Ion Specific, Potassium
00386100002466Electrode, Ion Specific, Potassium
00386100002398Electrode, Ion Specific, Potassium
00386100001643Electrode, Ion Specific, Potassium

Maude Adverse Events

FLEXLABINPECO SA2020-03-05
FLEXLABINPECO SA2020-02-20
ACCELERATOR A3600INPECO SA2020-01-10
FLEXLABINPECO SA2019-11-29
PICCOLO RENAL FUNCTION PANELABAXIS, INC.2019-10-18
PICCOLO METLYTE 8 PANELABAXIS, INC.2019-09-16
APTIO AUTOMATIONINPECO SA2019-08-16
FLEXLABINPECO SA2019-08-09
APTIO AUTOMATIONINPECO SA2019-07-31
FLEXLABINPECO SA2019-07-19
VITROS CHEMISTRY PRODUCTS K+ SLIDESORTHO-CLINICAL DIAGNOSTICS2019-06-27
ISE INDIRECT K+ FOR GEN.2ROCHE DIAGNOSTICS2019-06-26
VITROS CHEMISTRY PRODUCTS K+ SLIDESORTHO-CLINICAL DIAGNOSTICS2019-06-24
ALINIQ AMSABBOTT MANUFACTURING INC2019-06-20
ACCELERATOR A3600INPECO SA2019-06-18
APTIO AUTOMATIONINPECO SA2019-05-15
VITROS CHEMISTRY PRODUCTS K+ SLIDESORTHO-CLINICAL DIAGNOSTICS2019-05-03
ACCELERATOR A3600INPECO SA2019-04-23
FLEXLABINPECO SA2019-04-05
ABL90 FLEX ANALYZERRADIOMETER MEDICAL APS2019-02-08
ISE INDIRECT K+ FOR GEN.2ROCHE DIAGNOSTICS2018-11-15
DIMENSION VISTA?SIEMENS HEALTHCARE DIAGNOSTICS INC.2018-09-28
DIMENSION VISTA?SIEMENS HEALTHCARE DIAGNOSTICS INC.2018-09-28
ROCHE OMNI ELECTRODE POTASSIUMROCHE DIAGNOSTICS2018-08-22
VITROS CHEMISTRY PRODUCTS K+ SLIDESORTHO-CLINICAL DIAGNOSTICS2018-06-18
POTASSIUM ELECTRODE COBAS INTEGRA 400/700/800ROCHE DIAGNOSTICS2018-06-13
VITROS CHEMISTRY PRODUCTS K+ SLIDESORTHO-CLINICAL DIAGNOSTICS2018-04-04
VITROS CHEMISTRY PRODUCTS K+ SLIDESORTHO-CLINICAL DIAGNOSTICS2018-03-29
DIMENSION VISTA?SIEMENS HEALTHCARE DIAGNOSTICS INC.2018-03-14
DIMENSION VISTA?SIEMENS HEALTHCARE DIAGNOSTICS INC.2018-03-14
ROCHE OMNI ELECTRODE POTASSIUMROCHE DIAGNOSTICS2018-03-02
ROCHE OMNI ELECTRODE POTASSIUMROCHE DIAGNOSTICS2018-02-28
VITROS CHEMISTRY PRODUCTS K+ SLIDESORTHO-CLINICAL DIAGNOSTICS2018-02-16
COBAS 6000 C (501) MODULEROCHE DIAGNOSTICS2018-01-24
ARCHITECT C16000 SYSTEMABBOTT MANUFACTURING INC2017-11-10
DIMENSION VISTA 500SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-11-09
ARCHITECT C16000 SYSTEMABBOTT MANUFACTURING INC2017-10-27
ARCHITECT C16000 SYSTEMABBOTT MANUFACTURING INC2017-10-27
COBAS 8000 COBAS ISE MODULE (DOUBLE)ROCHE DIAGNOSTICS2017-10-27
COBAS 8000 COBAS ISE MODULEROCHE DIAGNOSTICS2017-10-23
DIMENSION VISTA?SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW2017-10-19
ISE INDIRECT K+ FOR GEN.2ROCHE DIAGNOSTICS2017-10-09
ARCHITECT C16000 SYSTEMABBOTT MANUFACTURING INC2017-10-03
COBAS 6000 C501 MODULEROCHE DIAGNOSTICS2017-09-29
VITROS CHEMISTRY PRODUCTS K+ SLIDESORTHO-CLINICAL DIAGNOSTICS2017-09-28
ARCHITECT C8000 SYSTEMABBOTT MANUFACTURING INC2017-09-27
VITROS CHEMISTRY PRODUCTS K+ SLIDESORTHO-CLINICAL DIAGNOSTICS2017-09-25
COBAS 6000 C501 MODULEROCHE DIAGNOSTICS2017-09-15
UNICEL DXC 600 PRO SYNCHRON SYSTEMBECKMAN COULTER2017-09-15
COBAS 6000 C501 MODULEROCHE DIAGNOSTICS2017-09-14
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