FDA product code DAC: Complement C3b Activator, Antigen, Antiserum, Control
DAC is the FDA product code for complement c3b activator, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5260 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under DAC, from 2 different applicants. The average 510(k) review took 16 days (median 16).
Classification
| Field | Value |
|---|---|
| Device name | Complement C3b Activator, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5260 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DAC clearance
Top DAC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diamedix Corp. | 1 | 1989-04-14 |
| Burroughs Wellcome Co. | 1 | 1977-09-02 |
Most recent DAC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K891904 | Diamedix Corp. | EZ COMPLEMENT C1 | 1989-04-14 | 18 |
| K771583 | Burroughs Wellcome Co. | FLUORESCENT ANTI. ANTI-HUMAN C3 | 1977-09-02 | 15 |
Recalls for DAC devices
openFDA lists no recalls for product code DAC.
Frequently asked questions
What is FDA product code DAC?
DAC is the FDA product code for complement c3b activator, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5260 and reviewed by the Immunology panel.
What device class is DAC?
Class II, regulation 21 CFR 866.5260. Typical premarket route: 510(k).
How long does a 510(k) take for product code DAC?
Across 2 cleared submissions the average was 16 days from receipt to decision (median 16).
Which companies have the most DAC clearances?
Diamedix Corp. (1); Burroughs Wellcome Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DAC
- Run a recall and safety report across every DAC manufacturer
- Watch product code DAC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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