FDA product code DCE: Fab, Antigen, Antiserum, Control
DCE is the FDA product code for fab, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5520 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under DCE. The average 510(k) review took 49 days (median 49).
Classification
| Field | Value |
|---|---|
| Device name | Fab, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5520 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DCE clearance
Top DCE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kallestad Laboratories, Inc. | 2 | 1979-02-16 |
Most recent DCE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K781951 | Kallestad Laboratories, Inc. | ANTISERA, RHODAMINE CONJUGATED FRAGMENT | 1979-02-16 | 87 |
| K772128 | Kallestad Laboratories, Inc. | FLUORESCEIN CONJUGATED | 1977-11-22 | 11 |
Recalls for DCE devices
openFDA lists no recalls for product code DCE.
Frequently asked questions
What is FDA product code DCE?
DCE is the FDA product code for fab, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5520 and reviewed by the Immunology panel.
What device class is DCE?
Class I, regulation 21 CFR 866.5520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DCE?
Across 2 cleared submissions the average was 49 days from receipt to decision (median 49).
Which companies have the most DCE clearances?
Kallestad Laboratories, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code DCE
- Run a recall and safety report across every DCE manufacturer
- Watch product code DCE 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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