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 |
| K980367 | ABBOTT LABORATORIES | AEROSET SYSTEM | 04/01/1998 |
| K170320 | Abbott Laboratories | Alinity c ICT Sample Diluent | 10/24/2017 |
| 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 |
| K981270 | DIAMETRICS MEDICAL, INC. | IRMA BLOOD ANALYSIS SYSTEM | 05/01/1998 |
| 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 |
| 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 |
| K182072 | Ortho-Clinical Diagnostics, Inc. | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides | 10/30/2018 |
| 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 |
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