FDA product code DEO: Kappa, Fitc, Antigen, Antiserum, Control
DEO is the FDA product code for kappa, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under DEO, from 2 different applicants. The average 510(k) review took 79 days (median 79).
Classification
| Field | Value |
|---|---|
| Device name | Kappa, Fitc, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5550 |
| 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 DEO clearance
Top DEO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gelco Diagnostics, Inc. | 1 | 1983-10-31 |
| Dako Corp. | 1 | 1983-07-19 |
Most recent DEO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832260 | Gelco Diagnostics, Inc. | GOAT ANTI-HUMAN KAPPA AFFINITY | 1983-10-31 | 123 |
| K831904 | Dako Corp. | RABBIT ANTISERUM TO HUMAN KAPPA LIGHT | 1983-07-19 | 35 |
Recalls for DEO devices
openFDA lists no recalls for product code DEO.
Frequently asked questions
What is FDA product code DEO?
DEO is the FDA product code for kappa, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Immunology panel.
What device class is DEO?
Class II, regulation 21 CFR 866.5550. Typical premarket route: 510(k).
How long does a 510(k) take for product code DEO?
Across 2 cleared submissions the average was 79 days from receipt to decision (median 79).
Which companies have the most DEO clearances?
Gelco Diagnostics, Inc. (1); Dako Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DEO
- Run a recall and safety report across every DEO manufacturer
- Watch product code DEO 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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