CGZClass II
Electrode, Ion-Specific, Chloride
21 CFR 862.1170 / Clinical Chemistry
CGZ is the FDA product code for Electrode, Ion-Specific, Chloride, a class II device type, regulated under 21 CFR 862.1170. As of , FDA records hold 38 510(k) clearances under this code, the most recent dated , and 11 recalls.
Classification record
- Product code
- CGZ
- Device name
- Electrode, Ion-Specific, Chloride
- Regulation
- 21 CFR 862.1170
- Device class
- Class II
- Review panel
- Clinical Chemistry
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 38
- Ingested recalls
- 11
Clearances, product code CGZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1984 | 1 |
| 1986 | 2 |
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 1 |
| 1991 | 2 |
| 1992 | 1 |
| 1994 | 1 |
| 1995 | 3 |
| 1996 | 2 |
| 1997 | 3 |
| 1998 | 3 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 3 |
| 2002 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
Applicants with the most clearances
Product code CGZ| Applicant | Clearances |
|---|---|
| Wallac Oy | 4 |
| Abbott Medical | 3 |
| Hichem Diagnostics | 3 |
| Ortho-Clinical Diagnostics, Inc. | 3 |
| Alko Diagnostic Corp. | 2 |
| Medica Corp. | 2 |
| Nova Biomedical Corporation | 2 |
| Olympus Corp. | 2 |
| Phoenix Diagnostics, Inc. | 2 |
| A.P. Total Care, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.