FDA product code DEY: Igm, Peroxidase, Antigen, Antiserum, Control
DEY is the FDA product code for igm, 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 3 510(k) submissions under DEY. The average 510(k) review took 88 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | Igm, 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 DEY clearance
Top DEY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ventana Medical Systems, Inc. | 3 | 1993-08-09 |
Most recent DEY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932386 | Ventana Medical Systems, Inc. | VENTANA RED DETECTION KIT | 1993-08-09 | 84 |
| K920600 | Ventana Medical Systems, Inc. | DAB DETECTION KIT | 1992-05-11 | 90 |
| K920566 | Ventana Medical Systems, Inc. | AEC DETECTION KIT | 1992-05-08 | 91 |
Recalls for DEY devices
openFDA lists no recalls for product code DEY.
Frequently asked questions
What is FDA product code DEY?
DEY is the FDA product code for igm, 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 DEY?
Class II, regulation 21 CFR 866.5550. Typical premarket route: 510(k).
How long does a 510(k) take for product code DEY?
Across 3 cleared submissions the average was 88 days from receipt to decision (median 90).
Which companies have the most DEY clearances?
Ventana Medical Systems, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code DEY
- Run a recall and safety report across every DEY manufacturer
- Watch product code DEY 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.
All Pathology product codes · FDA product code lookup · 510(k) database search · 510(k) review times