Product code CGZ
- Device name
- Electrode, Ion-Specific, Chloride
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1170
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides | Ortho-Clinical Diagnostics, Inc. | 2018-10-30 |
| K170320 | Alinity c ICT Sample Diluent | Abbott Laboratories | 2017-10-24 |
| K162020 | VITROS Chemistry Products Cl- Slides | Ortho Clinical Diagnostics | 2016-12-16 |
| K082099 | VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905 | Ortho-Clinical Diagnostics, Inc. | 2008-08-21 |
| K070889 | AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 | Wallac OY | 2008-04-14 |
| K070531 | ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER | Thermo Fisher Scientific | 2007-09-04 |
| K060108 | COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 | Roche Diagnostics Corp. | 2006-02-16 |
| K052027 | OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 | Osmetech, Inc. | 2005-09-29 |
| K020148 | pHoenix ISE Reagents FOR Olympus AU Chemistry Systems | Phoenix Diagnostics, Inc. | 2002-02-04 |
| K013451 | PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES | Phoenix Diagnostics, Inc. | 2001-12-18 |
| K003664 | DELFIA NEONATAL IRT KIT, MODEL A005-110 | Wallac OY | 2001-02-14 |
| K003668 | AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 | Wallac OY | 2001-02-12 |
| K993697 | DELFIA NEONATAL IRT KIT | Wallac OY | 2000-06-09 |
| K000926 | EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER | Medica Corp. | 2000-05-15 |
| K991870 | ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03 | A.P. Total Care, Inc. | 1999-07-30 |
| K981270 | IRMA BLOOD ANALYSIS SYSTEM | Diametrics Medical, Inc. | 1998-05-01 |
| K980757 | ILAB 600 CLINICAL CHEMISTRY SYSTEM | Instrumentation Laboratory CO | 1998-04-21 |
| K980367 | AEROSET SYSTEM | Abbott Laboratories | 1998-04-01 |
| K973742 | SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM | Sendx Medical, Inc. | 1997-12-03 |
| K972004 | ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS | Alko Diagnostic Corp. | 1997-06-16 |
| K962479 | SYNERMED ISE REAGENTS | Synermed, Inc. | 1997-03-03 |
| K963992 | CAPILLARY ADAPTOR ACCESSORY | Medica Corp. | 1996-11-29 |
| K963734 | ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS | Alko Diagnostic Corp. | 1996-10-24 |
| K953860 | HICHEM ISE DILUENT KIT 70008 | Hichem Diagnostics | 1995-09-06 |
| K953862 | HICHEM ISEKCI SOLUTION KIT 70010 | Hichem Diagnostics | 1995-09-06 |
| K953861 | HICHEM ISE INTDERNAL REFERENCE KIT 70009 | Hichem Diagnostics | 1995-09-06 |
| K935228 | MODEL 644 SWEAT DILUENT | Ciba Corning Diagnostics Corp. | 1994-08-01 |
| K924864 | NOVA 13 ANALYZER, MODIFICATION | Nova Biomedical Corp. | 1992-11-06 |
| K912561 | NOVA 13 ANALYZER | Nova Biomedical Corp. | 1991-09-11 |
| K912647 | ISE/CI- | Boehringer Mannheim Corp. | 1991-07-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10758750031658 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2023-04-28 |
| 10054749005519 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-05-01 |
| 08426950807582 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807827 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 450 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807810 | GEM Premier 5000 PAK BG/ISE/GL/COOX 450 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807803 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 450 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807797 | GEM Premier 5000 PAK BG/ISE/COOX 450 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807766 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 300 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807759 | GEM Premier 5000 PAK BG/ISE/GL/COOX 300 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807742 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 300 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807735 | GEM Premier 5000 PAK BG/ISE/COOX 300 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807698 | GEM Premier 5000 PAK BG/ISE/GL/COOX 150 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807681 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 150 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807674 | GEM Premier 5000 PAK BG/ISE/COOX 150 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807643 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 75 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807636 | GEM Premier 5000 PAK BG/ISE/GL/COOX 75 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807629 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 75 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807612 | GEM Premier 5000 PAK BG/ISE/COOX 75 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807605 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 600 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807704 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 150 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807575 | GEM Premier 5000 PAK BG/ISE/COOX 600 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807599 | GEM Premier 5000 PAK BG/ISE/GL/COOX 600 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08430215015353 | Chloride Electrode | Roche Diagnostics GmbH | 2016-09-20 |
| 08430215043561 | Chloride Electrode | Roche Diagnostics GmbH | 2016-09-20 |
| 00380740000370 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740000400 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740001179 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740019327 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740003814 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740003821 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |