DACClass II
Complement C3b Activator, Antigen, Antiserum, Control
21 CFR 866.5260 / Immunology
DAC is the FDA product code for Complement C3b Activator, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5260. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- DAC
- Device name
- Complement C3b Activator, Antigen, Antiserum, Control
- Regulation
- 21 CFR 866.5260
- 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
- 2
- Ingested recalls
- 0
Clearances, product code DAC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1989 | 1 |
Applicants with the most clearances
Product code DAC| Applicant | Clearances |
|---|---|
| Burroughs Wellcome Co. | 1 |
| Diamedix 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.
