FDA product code DES: Lambda, Fitc, Antigen, Antiserum, Control
DES is the FDA product code for lambda, 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 DES, from 2 different applicants. The average 510(k) review took 79 days (median 79).
Classification
| Field | Value |
|---|---|
| Device name | Lambda, 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 DES clearance
Top DES applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gelco Diagnostics, Inc. | 1 | 1983-10-31 |
| Dako Corp. | 1 | 1983-07-19 |
Most recent DES clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832267 | Gelco Diagnostics, Inc. | FITC GOAT ANTI-HUMAN LAMBA | 1983-10-31 | 123 |
| K831903 | Dako Corp. | FLUORESCEIN CONJUGATED IMMUNOGLOBULIN | 1983-07-19 | 35 |
Recalls for DES devices
openFDA lists no recalls for product code DES.
Frequently asked questions
What is FDA product code DES?
DES is the FDA product code for lambda, 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 DES?
Class II, regulation 21 CFR 866.5550. Typical premarket route: 510(k).
How long does a 510(k) take for product code DES?
Across 2 cleared submissions the average was 79 days from receipt to decision (median 79).
Which companies have the most DES clearances?
Gelco Diagnostics, Inc. (1); Dako Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DES
- Run a recall and safety report across every DES manufacturer
- Watch product code DES 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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