CGXClass II
Alkaline Picrate, Colorimetry, Creatinine
21 CFR 862.1225 / Clinical Chemistry
CGX is the FDA product code for Alkaline Picrate, Colorimetry, Creatinine, a class II device type, regulated under 21 CFR 862.1225. As of , FDA records hold 159 510(k) clearances under this code, the most recent dated , and 15 recalls.
Classification record
- Product code
- CGX
- Device name
- Alkaline Picrate, Colorimetry, Creatinine
- Regulation
- 21 CFR 862.1225
- 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
- 159
- Ingested recalls
- 15
Clearances, product code CGX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 15 |
| 1978 | 3 |
| 1979 | 8 |
| 1980 | 4 |
| 1981 | 7 |
| 1982 | 5 |
| 1983 | 8 |
| 1984 | 9 |
| 1985 | 7 |
| 1986 | 8 |
| 1987 | 8 |
| 1988 | 5 |
| 1989 | 3 |
| 1990 | 8 |
| 1991 | 5 |
| 1992 | 6 |
| 1993 | 5 |
| 1994 | 5 |
| 1995 | 4 |
| 1996 | 2 |
| 1997 | 3 |
| 1998 | 4 |
| 1999 | 2 |
| 2000 | 4 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 4 |
| 2009 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2016 | 1 |
| 2022 | 1 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code CGX| Applicant | Clearances |
|---|---|
| Em Diagnostic Systems, Inc. | 10 |
| Abbott Medical | 8 |
| Siemens Healthcare Diagnostics Inc. | 8 |
| Harleco | 8 |
| Olympus Corp. | 6 |
| American Research Products Co. | 3 |
| Amresco, Inc. | 3 |
| Hi Chem, Inc. | 3 |
| Roche Diagnostic Systems, Inc. | 3 |
| Sigma Diagnostics, Inc. | 3 |
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.