CGZ · Electrode, Ion-Specific, Chloride
Clinical Chemistry · 21 CFR 862.1170 · Class 2
Overview
| Product Code | CGZ |
|---|---|
| Device Name | Electrode, Ion-Specific, Chloride |
| Regulation | 21 CFR 862.1170 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 38)
Showing 20 most recent of 38 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides | Ortho-Clinical Diagnostics, Inc. | Oct 30, 2018 | SESE |
| K170320 | Alinity c ICT Sample Diluent | Abbott Laboratories | Oct 24, 2017 | SESE |
| K162020 | VITROS Chemistry Products Cl- Slides | Ortho Clinical Diagnostics | Dec 16, 2016 | SESE |
| K082099 | VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905 | Ortho-Clinical Diagnostics, Inc. | Aug 21, 2008 | SESE |
| K070889 | AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 | Wallac OY | Apr 14, 2008 | SESE |
| K070531 | ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER | Thermo Fisher Scientific | Sep 4, 2007 | SESE |
| K060108 | COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 | Roche Diagnostics Corp. | Feb 16, 2006 | SESE |
| K052027 | OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 | Osmetech, Inc. | Sep 29, 2005 | SESE |
| K020148 | pHoenix ISE Reagents FOR Olympus AU Chemistry Systems | Phoenix Diagnostics, Inc. | Feb 4, 2002 | SESE |
| K013451 | PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES | Phoenix Diagnostics, Inc. | Dec 18, 2001 | SESE |
| K003664 | DELFIA NEONATAL IRT KIT, MODEL A005-110 | Wallac OY | Feb 14, 2001 | SESE |
| K003668 | AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 | Wallac OY | Feb 12, 2001 | SESE |
| K993697 | DELFIA NEONATAL IRT KIT | Wallac OY | Jun 9, 2000 | SESE |
| K000926 | EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER | Medica Corp. | May 15, 2000 | SESE |
| K991870 | ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03 | A.P. Total Care, Inc. | Jul 30, 1999 | SESE |
| K981270 | IRMA BLOOD ANALYSIS SYSTEM | Diametrics Medical, Inc. | May 1, 1998 | SESE |
| K980757 | ILAB 600 CLINICAL CHEMISTRY SYSTEM | Instrumentation Laboratory CO | Apr 21, 1998 | SESE |
| K980367 | AEROSET SYSTEM | Abbott Laboratories | Apr 1, 1998 | SESE |
| K973742 | SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM | Sendx Medical, Inc. | Dec 3, 1997 | SESE |
| K972004 | ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS | Alko Diagnostic Corp. | Jun 16, 1997 | SESE |
Top Applicants
- Wallac OY — 4 clearances
- Hichem Diagnostics — 3 clearances
- Abbott Laboratories — 3 clearances
- Phoenix Diagnostics, Inc. — 2 clearances
- Ortho-Clinical Diagnostics, Inc. — 2 clearances
