CGZ · Class II · 21 CFR 862.1170

FDA Product Code CGZ: Electrode, Ion-specific, Chloride

Leading manufacturers include Wallac OY, Hichem Diagnostics and Abbott Laboratories.

38
Total
38
Cleared
103d
Avg days
1979
Since
38 devices
25–38 of 38
Cleared Sep 06, 1995
HICHEM ISE INTDERNAL REFERENCE KIT 70009
K953861
Hichem Diagnostics
Chemistry · 20d
Cleared Sep 06, 1995
HICHEM ISEKCI SOLUTION KIT 70010
K953862
Hichem Diagnostics
Chemistry · 20d
Cleared Aug 01, 1994
MODEL 644 SWEAT DILUENT
K935228
Ciba Corning Diagnostics Corp.
Chemistry · 273d
Cleared Nov 06, 1992
NOVA 13 ANALYZER, MODIFICATION
K924864
Nova Biomedical Corp.
Chemistry · 56d
Cleared Sep 11, 1991
NOVA 13 ANALYZER
K912561
Nova Biomedical Corp.
Chemistry · 92d
Cleared Jul 17, 1991
ISE/CI-
K912647
Boehringer Mannheim Corp.
Chemistry · 30d
Cleared May 15, 1990
ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER
K900887
Abbott Laboratories
Chemistry · 78d
Cleared Aug 11, 1989
OLYMPUS ISE MODULE FOR AU5000
K893628
Olympus Corp.
Chemistry · 92d
Cleared Feb 03, 1989
OLYMPUS ISE MODULE
K885193
Olympus Corp.
Chemistry · 49d
Cleared May 27, 1986
SODIUM, POTASSIUM AND CHLORIDE PROCEDURE
K861669
Data Medical Associates, Inc.
Chemistry · 27d
Cleared Apr 07, 1986
ION-SPECIFIC ELECTRODE, CHLORIDE
K860668
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Dec 10, 1984
ISE REAGENTS FOR DEMAND ANALYZER
K844021
Advanced Biomedical Methods, Inc.
Chemistry · 56d