Product code CEM— Clinical Chemistry
QEA SODIUM/POTASSIUM ANALYZER
- Classification name
- Electrode, Ion Specific, Potassium
- Device class
- Class 2
- Regulation
- 21 CFR 862.1600
- Advisory panel
- Clinical Chemistry
- Total cleared
- 89
- First cleared
- Most recent
Market context for product code CEM
FDA has cleared devices under product code CEM between 1977 and 2026, filed by 61 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2023
- 2020
- 2012
- 2011
- 2010
- 2009
- 2007
- 2006
- 2004
- 2003
- 2001
- 1999
- 1998
Top applicants under product code CEM
Recent clearances under product code CEM
- K253491 — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions
- K241037 — ABL90 FLEX PLUS System
- K220396 — EasyStat 300
- K230890 — ISE Electrodes
- K200544 — SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
- K121012 — FLEXLAB 3.6, ACCELERATOR A3600
- K121040 — SMARTLYTE ELECTROLYTE ANALYZER
- K112995 — GEM PREMIER 4000
- K110520 — BIOLIS 12I
- K112412 — AU5800(R) CHEMISTRY ANALYZER
- K112408 — POLY-CHEM 90 ISE MODULE
- K112788 — EASTLYTE NA/K/CA/PH
- K092686 — ABL90 FLEX SERIES
- K092849 — BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
- K093318 — ACCELERATOR APS
- K083680 — VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258
- K073157 — VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2
- K061107 — DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247
- K061730 — OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044
- K052914 — RX IMOLA
- K060373 — COBAS 6000 SERIES SYSTEM
- K042291 — UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
- K040750 — BIO-CHEM ANALYZER, MODEL 100
- K042270 — STAT K IN VITRO DIAGNOSTIC TEST SYSTEM
- K032311 — ROCHE DIAGNOSTICS OMNI S ANALYZER
- K013373 — OMNI C ANALYZER
- K010061 — DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
- K993083 — ALCYON 300I (WITH ISE MODULE) ANALYZER
- K974784 — AVL OPTI CRITICAL CARE ANALYZER
- K970330 — DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE
- K961326 — EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER
- K961115 — EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+)
- K932044 — DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD
- K922943 — NOVA NA/K/CL/LI MODULE
- K923038 — MILES POTASSIUM METHOD
- K915345 — STAT K SYSTEM
- K915177 — NOVA 5 NA/K/C1 ALALYZER
- K915178 — NOVA 11 NA/K/LI ANALYZER
- K912649 — ISE/K+
- K900788 — MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER
- K901039 — IONOMETER EH
- K901041 — IONOMETER EH-HK AND ACCESSORIES
- K900300 — LYTENING 2Z LYTENING SYSTEM 31
- K897110 — SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM
- K896692 — AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER
- K895664 — TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD
- K890792 — POTASSIUM AND SODIUM ELECTROLYTE ANALYZER
- K884769 — MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY
- K884566 — VISION LYTE (TM) POTASSIUM
- K883240 — AVL MODEL 986 ELECTROLYTE ANALYZER
- K870657 — AVL MODEL 985 ELECTROLYTE ANALYZER
- K870033 — AMRESCO FLOW PAC POTASSIUM REAGENT SET, #1460
- K854723 — SKD ELECTROCHEMICAL SYSTEM (ECS)
- K854298 — IRON
- K853068 — ILEX PROMPT CLINICAL CHEMISTRY ANALYER
- K853531 — ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER
- K853356 — SERA-210 ELECTROLYTE ANALYZER
- K850950 — VISION POTASSIUM
- K851100 — CHEM PRO 1000 CHEMISTRY ANALYSIS
- K851808 — ELECTROLYTE ANALYZER
- K851350 — ION 2 REAGENT KI
- K844955 — SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, &
- K844806 — MODIFY ELECTROLYTE ANALYZER MODEL SERA-210
- K843454 — ULTRA LYTE POTASSIUM REAGENT KIT
- K844044 — LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER
- K843239 — DACOS PLUS LYTES OPTION
- K842786 — DYNA-LYTE 2000
- K843008 — ION SELECTIVE ELECTRODES & REAGENT SYS
- K840961 — ESCHWEILER COMBI-ANALYSER MTA-500
- K842315 — ULTRA LYTE ANALYZER I 100
- K841575 — SENTECH'S ULAB 1000 CLINICAL CHEM.
- K840887 — AMRESCO E2A REAGENT SET 0562 & 0626
- K833696 — ACID BASE LABORATORY ABL4
- K833776 — QEA SODIUM/POTASSIUM ANALYZER
- K833159 — POTASSIUM ELECTRODE TIP ASSAMBLY-K-
- K832036 — QEA SODIUM/POTASSIUM ANALYZER
- K830104 — SERUM IRON DIAGNOSTIC TEST KITS
- K822441 — UNIMETER 330K
- K821822 — MODEL 1020 NA/K ANALYZER
- K811310 — SODIUM/POTASSIUM REAGENT KITS
- K802158 — POSTASSIUM BUFFER SOL. & WASH SOLUTION
- K800692 — REAGENT FOR DETERM. POTASSIUM/IN HUMAN
- K800054 — KODAK EKTACHEM ELECTROLYTE ANALYZER
- K800016 — DUPONT ACA ION SELECTIVE ELECTRODE
- K791692 — SODIUM/POTASSIUM BUFFER SOLUTION
- K791175 — ANALYZER, SODIUM/POTASSIUM
- K790018 — SERUM, POTASSIUM DETERMINATION OF
- K771837 — POTASSIUM
- K771118 — CENTRIA SEPARATION COLUMNS TYPE A
Data sourced from openFDA. This site is unofficial and independent of the FDA.