FDA product code DEN: Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control
DEN is the FDA product code for alpha-1-t-glycoprotein, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5420 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under DEN, from 2 different applicants. The average 510(k) review took 16 days (median 16).
Classification
| Field | Value |
|---|---|
| Device name | Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5420 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DEN clearance
Top DEN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Icl Scientific | 1 | 1978-03-17 |
| Hyland Therapeutic Div., Travenol Laboratories | 1 | 1977-10-19 |
Most recent DEN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K780325 | Icl Scientific | RID SYSTEM-HUMAN C-REACTIVE PROTEIN | 1978-03-17 | 18 |
| K771879 | Hyland Therapeutic Div., Travenol Laboratories | GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID | 1977-10-19 | 15 |
Recalls for DEN devices
openFDA lists no recalls for product code DEN.
Frequently asked questions
What is FDA product code DEN?
DEN is the FDA product code for alpha-1-t-glycoprotein, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5420 and reviewed by the Immunology panel.
What device class is DEN?
Class I, regulation 21 CFR 866.5420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DEN?
Across 2 cleared submissions the average was 16 days from receipt to decision (median 16).
Which companies have the most DEN clearances?
Icl Scientific (1); Hyland Therapeutic Div., Travenol Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DEN
- Run a recall and safety report across every DEN manufacturer
- Watch product code DEN 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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