CIBClass II
Radioimmunoassay, Angiotensin I And Renin
21 CFR 862.1085 / Clinical Chemistry
CIB is the FDA product code for Radioimmunoassay, Angiotensin I And Renin, a class II device type, regulated under 21 CFR 862.1085. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and 4 recalls.
Classification record
- Product code
- CIB
- Device name
- Radioimmunoassay, Angiotensin I And Renin
- Regulation
- 21 CFR 862.1085
- 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
- 16
- Ingested recalls
- 4
Clearances, product code CIB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1980 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 2 |
| 1985 | 1 |
| 1993 | 1 |
| 1995 | 2 |
| 1998 | 1 |
| 2001 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2013 | 2 |
Applicants with the most clearances
Product code CIB| Applicant | Clearances |
|---|---|
| Diagnostic Systems Laboratories, Inc. | 2 |
| Nichols Institute Diagnostics | 2 |
| Buhlmann Laboratories AG | 1 |
| Cis Bio International | 1 |
| Diasorin Inc. | 1 |
| E. R. Squibb & Sons, Inc. | 1 |
| E.I. Dupont de Nemours & Co., Inc. | 1 |
| Hoffmann-La Roche, Inc. | 1 |
| Immuno-Diagnostic Laboratories | 1 |
| Immunodiagnostic Systems Ltd. | 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.
