FDA product code DAQ: Igg (Fd Fragment Specific), Antigen, Antiserum, Control
DAQ is the FDA product code for igg (fd fragment specific), antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5540 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under DAQ. The average 510(k) review took 9 days (median 9). FDA has posted 1 recall for DAQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Igg (Fd Fragment Specific), Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5540 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DAQ clearance
Top DAQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helena Laboratories | 1 | 1989-03-22 |
Most recent DAQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K891299 | Helena Laboratories | MID-LEVEL IGG KIT CAT. NO. 9315 | 1989-03-22 | 9 |
Recalls for DAQ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-12-17.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code DAQ?
DAQ is the FDA product code for igg (fd fragment specific), antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5540 and reviewed by the Immunology panel.
What device class is DAQ?
Class I, regulation 21 CFR 866.5540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DAQ?
Across 1 cleared submissions the average was 9 days from receipt to decision (median 9).
Which companies have the most DAQ clearances?
Helena Laboratories (1).
Have DAQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-12-17.
Next steps
- Run an FDA pathway report with predicate devices for product code DAQ
- Run a recall and safety report across every DAQ manufacturer
- Watch product code DAQ 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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