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Panels › Clinical Chemistry › Product code CGZ · Class 2

Electrode, Ion-Specific, Chloride

Regulation 862.1170

0510(k)s in 12 months (38 all time)
0recalls in 12 months (11 all time)
11recalls that name a 510(k)
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Top companies in CGZ

Company510(k)sRecalls
Abbott Laboratories34
Ortho Clinical Diagnostics34
Wallac OY40
Hichem Diagnostics30
Alko Diagnostic Corp.20
Medica Corp.20
Nova Biomedical Corp.20
Olympus Corp.20
OPTI Medical Systems, Inc02
Phoenix Diagnostics, Inc.20
Decided510(k)Device and applicantCode
Oct 30, 2018K182072VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
Ortho-Clinical Diagnostics, Inc.
CGZ
Oct 24, 2017K170320Alinity c ICT Sample Diluent
Abbott Laboratories
CGZ
Dec 16, 2016K162020VITROS Chemistry Products Cl- Slides
Ortho Clinical Diagnostics
CGZ
Aug 21, 2008K082099VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905
Ortho-Clinical Diagnostics, Inc.
CGZ
Apr 14, 2008K070889AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
Wallac OY, FI
CGZ
Sep 4, 2007K070531ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER
Thermo Fisher Scientific
CGZ
Feb 16, 2006K060108COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
Roche Diagnostics Corp.
CGZ
Sep 29, 2005K052027OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200
Osmetech, Inc.
CGZ
Feb 4, 2002K020148pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
Phoenix Diagnostics, Inc.
CGZ
Dec 18, 2001K013451PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
Phoenix Diagnostics, Inc.
CGZ
Feb 14, 2001K003664DELFIA NEONATAL IRT KIT, MODEL A005-110
Wallac OY, FI
CGZ
Feb 12, 2001K003668AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
Wallac OY, FI
CGZ
Jun 9, 2000K993697DELFIA NEONATAL IRT KIT
Wallac OY, FI
CGZ
May 15, 2000K000926EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER
Medica Corp.
CGZ
Jul 30, 1999K991870ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
A.P. Total Care, Inc.
CGZ
May 1, 1998K981270IRMA BLOOD ANALYSIS SYSTEM
Diametrics Medical, Inc.
CGZ
Apr 21, 1998K980757ILAB 600 CLINICAL CHEMISTRY SYSTEM
Instrumentation Laboratory CO
CGZ
Apr 1, 1998K980367AEROSET SYSTEM
Abbott Laboratories
CGZ
Dec 3, 1997K973742SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
Sendx Medical, Inc.
CGZ
Jun 16, 1997K972004ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS
Alko Diagnostic Corp.
CGZ
Mar 3, 1997K962479SYNERMED ISE REAGENTS
Synermed, Inc., CA
CGZ
Nov 29, 1996K963992CAPILLARY ADAPTOR ACCESSORY
Medica Corp.
CGZ
Oct 24, 1996K963734ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS
Alko Diagnostic Corp.
CGZ
Sep 6, 1995K953862HICHEM ISEKCI SOLUTION KIT 70010
Hichem Diagnostics
CGZ
Sep 6, 1995K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009
Hichem Diagnostics
CGZ
Sep 6, 1995K953860HICHEM ISE DILUENT KIT 70008
Hichem Diagnostics
CGZ
Aug 1, 1994K935228MODEL 644 SWEAT DILUENT
Ciba Corning Diagnostics Corp.
CGZ
Nov 6, 1992K924864NOVA 13 ANALYZER, MODIFICATION
Nova Biomedical Corp.
CGZ
Sep 11, 1991K912561NOVA 13 ANALYZER
Nova Biomedical Corp.
CGZ
Jul 17, 1991K912647ISE/CI-
Boehringer Mannheim Corp.
CGZ
May 15, 1990K900887ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER
Abbott Laboratories
CGZ
Aug 11, 1989K893628OLYMPUS ISE MODULE FOR AU5000
Olympus Corp.
CGZ
Feb 3, 1989K885193OLYMPUS ISE MODULE
Olympus Corp.
CGZ
May 24, 1988K863395WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER
Wescor, Inc.
CGZ
May 27, 1986K861669SODIUM, POTASSIUM AND CHLORIDE PROCEDURE
Data Medical Associates, Inc.
CGZ
Apr 7, 1986K860668ION-SPECIFIC ELECTRODE, CHLORIDE
Em Diagnostic Systems, Inc.
CGZ
Dec 10, 1984K844021ISE REAGENTS FOR DEMAND ANALYZER
Advanced Biomedical Methods, Inc.
CGZ
Jun 15, 1979K790653NOVA 3 CHLORIDE/TOTAL DIOXIDE ANALYZER
Nova Corp.
CGZ

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