CFQClass II
Radioimmunoassay, Immunoglobulins (G, A, M)
21 CFR 866.5510 / Immunology
CFQ is the FDA product code for Radioimmunoassay, Immunoglobulins (G, A, M), a class II device type, regulated under 21 CFR 866.5510. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- CFQ
- Device name
- Radioimmunoassay, Immunoglobulins (G, A, M)
- Regulation
- 21 CFR 866.5510
- Device class
- Class II
- Review panel
- Immunology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 12
- Ingested recalls
- 0
Clearances, product code CFQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1988 | 3 |
| 1989 | 2 |
| 1995 | 3 |
| 1999 | 4 |
Applicants with the most clearances
Product code CFQ| Applicant | Clearances |
|---|---|
| The Binding Site | 4 |
| Siemens Healthcare Diagnostics Inc. | 3 |
| OLYMPUS Corporation of the Americas | 3 |
| Atlantic Antibodies | 1 |
| Helena Laboratories, Corp. | 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.
