CEM · Class II · 21 CFR 862.1600

FDA Product Code CEM: Electrode, Ion Specific, Potassium

Leading manufacturers include Nova Biomedical Corp., Abbott Laboratories and Avl Scientific Corp..

89
Total
89
Cleared
90d
Avg days
1977
Since
89 devices
25–48 of 89
Cleared Feb 24, 1998
AVL OPTI CRITICAL CARE ANALYZER
K974784
Avl Scientific Corp.
Chemistry · 64d
Cleared Apr 14, 1997
DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE
K970330
Dade Intl., Inc.
Chemistry · 76d
Cleared Jun 21, 1996
EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER
K961326
Medica Corp.
Chemistry · 74d
Cleared May 07, 1996
EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+)
K961115
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 48d
Cleared Jul 27, 1993
DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD
K932044
Dupont Medical Products
Chemistry · 91d
Cleared Oct 13, 1992
NOVA NA/K/CL/LI MODULE
K922943
Nova Biomedical Corp.
Chemistry · 117d
Cleared Aug 24, 1992
MILES POTASSIUM METHOD
K923038
Heraeus Kulzer, Inc.
Chemistry · 66d
Cleared Jan 27, 1992
NOVA 5 NA/K/C1 ALALYZER
K915177
Nova Biomedical Corp.
Chemistry · 73d
Cleared Jan 27, 1992
NOVA 11 NA/K/LI ANALYZER
K915178
Nova Biomedical Corp.
Chemistry · 73d
Cleared Jul 15, 1991
ISE/K+
K912649
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Jun 28, 1990
IONOMETER EH
K901039
Fresenius USA, Inc.
Chemistry · 114d
Cleared Jun 18, 1990
IONOMETER EH-HK AND ACCESSORIES
K901041
Fresenius USA, Inc.
Chemistry · 104d
Cleared Mar 01, 1990
LYTENING 2Z LYTENING SYSTEM 31
K900300
Baxter Healthcare Corp
Chemistry · 38d
Cleared Jan 02, 1990
AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER
K896692
Baxter Healthcare Corp
Chemistry · 35d
Cleared Nov 14, 1989
TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD
K895664
Technicon Instruments Corp.
Chemistry · 55d
Cleared Jan 17, 1989
MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY
K884769
Ciba Corning Diagnostics Corp.
Chemistry · 64d
Cleared Dec 02, 1988
VISION LYTE (TM) POTASSIUM
K884566
Abbott Laboratories
Chemistry · 31d
Cleared Sep 22, 1988
AVL MODEL 986 ELECTROLYTE ANALYZER
K883240
Avl Scientific Corp.
Chemistry · 52d
Cleared May 12, 1987
AVL MODEL 985 ELECTROLYTE ANALYZER
K870657
Avl Scientific Corp.
Chemistry · 83d
Cleared Jan 21, 1987
AMRESCO FLOW PAC POTASSIUM REAGENT SET, #1460
K870033
American Research Products Co.
Chemistry · 16d
Cleared Mar 05, 1986
SKD ELECTROCHEMICAL SYSTEM (ECS)
K854723
Smithkline Diagnostics, Inc.
Chemistry · 103d
Cleared Nov 12, 1985
IRON
K854298
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Sep 04, 1985
ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER
K853531
American Dade
Chemistry · 12d
Cleared Aug 12, 1985
VISION POTASSIUM
K850950
Abbott Laboratories
Chemistry · 158d