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
49–72 of 89
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 14, 1984
DYNA-LYTE 2000
K842786
Abbott Diagnostics
Chemistry · 115d
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
Cleared May 28, 1980
REAGENT FOR DETERM. POTASSIUM/IN HUMAN
K800692
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared Feb 05, 1980
KODAK EKTACHEM ELECTROLYTE ANALYZER
K800054
Eastman Kodak Company
Chemistry · 27d
Cleared Jan 21, 1980
DUPONT ACA ION SELECTIVE ELECTRODE
K800016
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 14d
Cleared Sep 17, 1979
SODIUM/POTASSIUM BUFFER SOLUTION
K791692
Hi Chem, Inc.
Chemistry · 48d
Cleared Aug 10, 1979
ANALYZER, SODIUM/POTASSIUM
K791175
Nova Biomedical Corp.
Chemistry · 46d
Cleared Feb 01, 1979
SERUM, POTASSIUM DETERMINATION OF
K790018
Fisher Scientific Co., LLC
Chemistry · 29d
Cleared Nov 02, 1977
POTASSIUM
K771837
Gamma Enterprises, Inc.
Chemistry · 42d