CIGClass II
Diazo Colorimetry, Bilirubin
21 CFR 862.1110 / Clinical Chemistry
CIG is the FDA product code for Diazo Colorimetry, Bilirubin, a class II device type, regulated under 21 CFR 862.1110. As of , FDA records hold 235 510(k) clearances under this code, the most recent dated , and 19 recalls.
Classification record
- Product code
- CIG
- Device name
- Diazo Colorimetry, Bilirubin
- Regulation
- 21 CFR 862.1110
- 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
- 235
- Ingested recalls
- 19
Clearances, product code CIG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 7 |
| 1977 | 6 |
| 1978 | 3 |
| 1979 | 7 |
| 1980 | 5 |
| 1981 | 5 |
| 1982 | 5 |
| 1983 | 9 |
| 1984 | 18 |
| 1985 | 6 |
| 1986 | 18 |
| 1987 | 14 |
| 1988 | 12 |
| 1989 | 13 |
| 1990 | 14 |
| 1991 | 9 |
| 1992 | 8 |
| 1993 | 4 |
| 1994 | 4 |
| 1995 | 1 |
| 1996 | 3 |
| 1997 | 4 |
| 1998 | 13 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 4 |
| 2002 | 4 |
| 2003 | 3 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 7 |
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 2 |
| 2013 | 5 |
| 2015 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2026 | 1 |
Applicants with the most clearances
Product code CIG| Applicant | Clearances |
|---|---|
| Em Diagnostic Systems, Inc. | 21 |
| Abbott Medical | 15 |
| Data Medical Associates, Inc. | 10 |
| Synermed, Inc. | 7 |
| Siemens Healthcare Diagnostics Inc. | 6 |
| Harleco | 6 |
| Diagnostic Chemicals, Ltd. (USA) | 5 |
| American Research Products Co. | 4 |
| Catachem, Inc. | 4 |
| J.T. Baker Chemical Co. | 4 |
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.