CEM · Class II · 21 CFR 862.1600

FDA Product Code CEM: Electrode, Ion Specific, Potassium

Leading manufacturers include Nova Biomedical Corp., Abbott Laboratories and Hi Chem, Inc..

89
Total
89
Cleared
90d
Avg days
1977
Since
89 devices
25–48 of 89
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 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
Cleared Apr 29, 1985
ION 2 REAGENT KI
K851350
Hi Chem, Inc.
Chemistry · 25d
Cleared Mar 19, 1985
SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, &
K844955
Miles Laboratories, Inc.
Chemistry · 88d
Cleared Nov 27, 1984
LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER
K844044
Medica Corp.
Chemistry · 41d
Cleared Oct 17, 1984
DACOS PLUS LYTES OPTION
K843239
Coulter Electronics, Inc.
Pathology · 56d
Cleared Sep 04, 1984
ION SELECTIVE ELECTRODES & REAGENT SYS
K843008
American Monitor Corp.
Chemistry · 35d
Cleared Apr 18, 1984
AMRESCO E2A REAGENT SET 0562 & 0626
K840887
American Research Products Co.
Chemistry · 51d
Cleared Jan 18, 1984
ACID BASE LABORATORY ABL4
K833696
Radiometer America, Inc.
Chemistry · 92d
Cleared Dec 29, 1983
QEA SODIUM/POTASSIUM ANALYZER
K833776
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 63d
Cleared Nov 25, 1983
POTASSIUM ELECTRODE TIP ASSAMBLY-K-
K833159
Hi Chem, Inc.
Chemistry · 70d
Cleared Jul 18, 1983
QEA SODIUM/POTASSIUM ANALYZER
K832036
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 24d
Cleared Jan 28, 1983
SERUM IRON DIAGNOSTIC TEST KITS
K830104
Sclavo, Inc.
Chemistry · 17d
Cleared Oct 08, 1982
UNIMETER 330K
K822441
Boehringer Mannheim Corp.
Chemistry · 53d