CKGClass II
Radioimmunoassay, Acth
21 CFR 862.1025 / Clinical Chemistry
CKG is the FDA product code for Radioimmunoassay, Acth, a class II device type, regulated under 21 CFR 862.1025. As of , FDA records hold 30 510(k) clearances under this code, the most recent dated , and 6 recalls.
Classification record
- Product code
- CKG
- Device name
- Radioimmunoassay, Acth
- Regulation
- 21 CFR 862.1025
- 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
- 30
- Ingested recalls
- 6
Clearances, product code CKG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 3 |
| 1984 | 6 |
| 1985 | 2 |
| 1986 | 1 |
| 1988 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1996 | 3 |
| 1998 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2011 | 1 |
| 2023 | 1 |
Applicants with the most clearances
Product code CKG| Applicant | Clearances |
|---|---|
| Diagnostic Systems Laboratories, Inc. | 3 |
| Nichols Institute Diagnostics | 3 |
| Siemens Healthcare Diagnostics Inc. | 2 |
| Immuno Nuclear Corp. | 2 |
| Scantibodies Laboratory Inc. | 2 |
| Syncor Intl. Corp. | 2 |
| Clinetics Corp. | 1 |
| Compagnie Oris Industrie, S.A. | 1 |
| Damon Corp. | 1 |
| Euro-Diagnostics BV | 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.