FDA 510(k) Applications for Medical Device Product Code "CGZ"
(Electrode, Ion-Specific, Chloride)

FDA 510(k) Number Applicant Device Name Decision Date
K991870 A.P. TOTAL CARE, INC. ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03 07/30/1999
K900887 ABBOTT LABORATORIES ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER 05/15/1990
K980367 ABBOTT LABORATORIES AEROSET SYSTEM 04/01/1998
K170320 Abbott Laboratories Alinity c ICT Sample Diluent 10/24/2017
K844021 ADVANCED BIOMEDICAL METHODS, INC. ISE REAGENTS FOR DEMAND ANALYZER 12/10/1984
K963734 ALKO DIAGNOSTIC CORP. ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS 10/24/1996
K972004 ALKO DIAGNOSTIC CORP. ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS 06/16/1997
K912647 BOEHRINGER MANNHEIM CORP. ISE/CI- 07/17/1991
K935228 CIBA CORNING DIAGNOSTICS CORP. MODEL 644 SWEAT DILUENT 08/01/1994
K861669 DATA MEDICAL ASSOCIATES, INC. SODIUM, POTASSIUM AND CHLORIDE PROCEDURE 05/27/1986
K981270 DIAMETRICS MEDICAL, INC. IRMA BLOOD ANALYSIS SYSTEM 05/01/1998
K860668 EM DIAGNOSTIC SYSTEMS, INC. ION-SPECIFIC ELECTRODE, CHLORIDE 04/07/1986
K953860 HICHEM DIAGNOSTICS HICHEM ISE DILUENT KIT 70008 09/06/1995
K953861 HICHEM DIAGNOSTICS HICHEM ISE INTDERNAL REFERENCE KIT 70009 09/06/1995
K953862 HICHEM DIAGNOSTICS HICHEM ISEKCI SOLUTION KIT 70010 09/06/1995
K980757 INSTRUMENTATION LABORATORY CO. ILAB 600 CLINICAL CHEMISTRY SYSTEM 04/21/1998
K963992 MEDICA CORP. CAPILLARY ADAPTOR ACCESSORY 11/29/1996
K000926 MEDICA CORP. EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER 05/15/2000
K912561 NOVA BIOMEDICAL CORP. NOVA 13 ANALYZER 09/11/1991
K924864 NOVA BIOMEDICAL CORP. NOVA 13 ANALYZER, MODIFICATION 11/06/1992
K790653 NOVA CORP. NOVA 3 CHLORIDE/TOTAL DIOXIDE ANALYZER 06/15/1979
K885193 OLYMPUS CORP. OLYMPUS ISE MODULE 02/03/1989
K893628 OLYMPUS CORP. OLYMPUS ISE MODULE FOR AU5000 08/11/1989
K162020 Ortho Clinical Diagnostics VITROS Chemistry Products Cl- Slides 12/16/2016
K082099 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905 08/21/2008
K052027 OSMETECH, INC. OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 09/29/2005
K020148 PHOENIX DIAGNOSTICS, INC. pHoenix ISE Reagents FOR Olympus AU Chemistry Systems 02/04/2002
K013451 PHOENIX DIAGNOSTICS, INC. PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES 12/18/2001
K060108 ROCHE DIAGNOSTICS CORP. COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 02/16/2006
K973742 SENDX MEDICAL, INC. SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM 12/03/1997
K962479 SYNERMED, INC. SYNERMED ISE REAGENTS 03/03/1997
K070531 Thermo Fisher Scientific ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER 09/04/2007
K003668 WALLAC OY AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 02/12/2001
K070889 WALLAC OY AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 04/14/2008
K993697 WALLAC OY DELFIA NEONATAL IRT KIT 06/09/2000
K003664 WALLAC OY DELFIA NEONATAL IRT KIT, MODEL A005-110 02/14/2001
K863395 WESCOR, INC. WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER 05/24/1988


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact