CGZ · Class II · 21 CFR 862.1170

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

Leading manufacturers include Hichem Diagnostics, Abbott Laboratories and Olympus Corp..

38
Total
38
Cleared
103d
Avg days
1979
Since

FDA 510(k) Cleared Electrode, Ion-specific, Chloride Devices (Product Code CGZ)

38 devices
1–24 of 38
Cleared Oct 30, 2018
VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
K182072
Ortho-Clinical Diagnostics, Inc.
Chemistry · 90d
Cleared Oct 24, 2017
Alinity c ICT Sample Diluent
K170320
Abbott Laboratories
Chemistry · 265d
Cleared Dec 16, 2016
VITROS Chemistry Products Cl- Slides
K162020
Ortho-Clinical Diagnostics
Chemistry · 148d
Cleared Aug 21, 2008
VITROS CHEMISTRY PRODUCTS CI-DT SLIDES
K082099
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d
Cleared Sep 04, 2007
ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER
K070531
Thermo Fisher Scientific
Chemistry · 193d
Cleared Feb 16, 2006
COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
K060108
Roche Diagnostics Corp.
Chemistry · 34d
Cleared May 15, 2000
EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER
K000926
Medica Corp.
Chemistry · 54d
Cleared Apr 21, 1998
ILAB 600 CLINICAL CHEMISTRY SYSTEM
K980757
Instrumentation Laboratory CO
Chemistry · 53d
Cleared Apr 01, 1998
AEROSET SYSTEM
K980367
Abbott Laboratories
Chemistry · 62d
Cleared Mar 03, 1997
SYNERMED ISE REAGENTS
K962479
Synermed, Inc.
Chemistry · 250d
Cleared Nov 29, 1996
CAPILLARY ADAPTOR ACCESSORY
K963992
Medica Corp.
Toxicology · 56d
Cleared Sep 06, 1995
HICHEM ISE DILUENT KIT 70008
K953860
Hichem Diagnostics
Chemistry · 20d
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

About Product Code CGZ - Regulatory Context