CGZ — Electrode, Ion-Specific, Chloride Class II
FDA product code CGZ covers "Electrode, Ion-Specific, Chloride", a Class II medical device regulated under 21 CFR 862.1170. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CGZ
- Device Class
- Class II
- Regulation Number
- 862.1170
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K182072 | ortho-clinical diagnostics | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITR | October 30, 2018 |
| K170320 | abbott laboratories | Alinity c ICT Sample Diluent | October 24, 2017 |
| K162020 | ortho clinical diagnostics | VITROS Chemistry Products Cl- Slides | December 16, 2016 |
| K082099 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR | August 21, 2008 |
| K070889 | wallac | AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 | April 14, 2008 |
| K070531 | thermo fisher scientific | ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALY | September 4, 2007 |
| K060108 | roche diagnostics | COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 | February 16, 2006 |
| K052027 | osmetech | OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 | September 29, 2005 |
| K020148 | phoenix diagnostics | pHoenix ISE Reagents FOR Olympus AU Chemistry Systems | February 4, 2002 |
| K013451 | phoenix diagnostics | PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES | December 18, 2001 |
| K003664 | wallac | DELFIA NEONATAL IRT KIT, MODEL A005-110 | February 14, 2001 |
| K003668 | wallac | AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 | February 12, 2001 |
| K993697 | wallac | DELFIA NEONATAL IRT KIT | June 9, 2000 |
| K000926 | medica | EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER | May 15, 2000 |
| K991870 | a.p. total care | ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03 | July 30, 1999 |
| K981270 | diametrics medical | IRMA BLOOD ANALYSIS SYSTEM | May 1, 1998 |
| K980757 | instrumentation laboratory | ILAB 600 CLINICAL CHEMISTRY SYSTEM | April 21, 1998 |
| K980367 | abbott laboratories | AEROSET SYSTEM | April 1, 1998 |
| K973742 | sendx medical | SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM | December 3, 1997 |
| K972004 | alko diagnostic | ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS | June 16, 1997 |