FDA product code DDE: Carbonic Anhydrase C, Antigen, Antiserum, Control
DDE is the FDA product code for carbonic anhydrase c, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5200 and reviewed by the Hematology panel. FDA has cleared 3 510(k) submissions under DDE, from 2 different applicants. The average 510(k) review took 40 days (median 29).
Classification
| Field | Value |
|---|---|
| Device name | Carbonic Anhydrase C, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5200 |
| Review panel | HE — Hematology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DDE clearance
Top DDE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Products Corp. | 2 | 1990-07-10 |
| Syva Co. | 1 | 1982-04-26 |
Most recent DDE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K902055 | Diagnostic Products Corp. | TENONE(TM) OPIATES CATALOG: VKSO1,4 | 1990-07-10 | 64 |
| K823680 | Diagnostic Products Corp. | COAT-A-COUNT MORPHINE KIT & COMPONENTS | 1983-01-05 | 29 |
| K820900 | Syva Co. | EMIT URINE METHADONE ASSAY #3E319 | 1982-04-26 | 26 |
Recalls for DDE devices
openFDA lists no recalls for product code DDE.
Frequently asked questions
What is FDA product code DDE?
DDE is the FDA product code for carbonic anhydrase c, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5200 and reviewed by the Hematology panel.
What device class is DDE?
Class I, regulation 21 CFR 866.5200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DDE?
Across 3 cleared submissions the average was 40 days from receipt to decision (median 29).
Which companies have the most DDE clearances?
Diagnostic Products Corp. (2); Syva Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DDE
- Run a recall and safety report across every DDE manufacturer
- Watch product code DDE 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 Hematology product codes · FDA product code lookup · 510(k) database search · 510(k) review times