FDA product code DEP: Lambda, Peroxidase, Antigen, Antiserum, Control
DEP is the FDA product code for lambda, peroxidase, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under DEP. The average 510(k) review took 57 days (median 57).
Classification
| Field | Value |
|---|---|
| Device name | Lambda, Peroxidase, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5550 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DEP clearance
Top DEP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| J.T. Baker Chemical Co. | 1 | 1980-09-16 |
Most recent DEP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K801662 | J.T. Baker Chemical Co. | J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. | 1980-09-16 | 57 |
Recalls for DEP devices
openFDA lists no recalls for product code DEP.
Frequently asked questions
What is FDA product code DEP?
DEP is the FDA product code for lambda, peroxidase, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Pathology panel.
What device class is DEP?
Class II, regulation 21 CFR 866.5550. Typical premarket route: 510(k).
How long does a 510(k) take for product code DEP?
Across 1 cleared submissions the average was 57 days from receipt to decision (median 57).
Which companies have the most DEP clearances?
J.T. Baker Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DEP
- Run a recall and safety report across every DEP manufacturer
- Watch product code DEP 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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