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

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 Apr 14, 2008
AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
K070889
Wallac OY
Chemistry · 381d
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 Feb 04, 2002
pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
K020148
Phoenix Diagnostics, Inc.
Chemistry · 19d
Cleared Dec 18, 2001
PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
K013451
Phoenix Diagnostics, Inc.
Chemistry · 61d
Cleared Feb 14, 2001
DELFIA NEONATAL IRT KIT, MODEL A005-110
K003664
Wallac OY
Chemistry · 78d
Cleared Feb 12, 2001
AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
K003668
Wallac OY
Chemistry · 76d
Cleared Jun 09, 2000
DELFIA NEONATAL IRT KIT
K993697
Wallac OY
Chemistry · 220d
Cleared May 15, 2000
EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER
K000926
Medica Corp.
Chemistry · 54d
Cleared Jul 30, 1999
ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
K991870
A.P. Total Care, Inc.
Chemistry · 59d
Cleared May 01, 1998
IRMA BLOOD ANALYSIS SYSTEM
K981270
Diametrics Medical, Inc.
Chemistry · 24d
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 Dec 03, 1997
SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
K973742
Sendx Medical, Inc.
Chemistry · 63d
Cleared Jun 16, 1997
ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS
K972004
Alko Diagnostic Corp.
Chemistry · 17d
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 Oct 24, 1996
ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS
K963734
Alko Diagnostic Corp.
Chemistry · 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

About Product Code CGZ - Regulatory Context