FDA product code DDB: Ceruloplasmin, Antigen, Antiserum, Control
DDB is the FDA product code for ceruloplasmin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5210 and reviewed by the Immunology panel. FDA has cleared 19 510(k) submissions under DDB, from 15 different applicants. The average 510(k) review took 99 days (median 57).
Classification
| Field | Value |
|---|---|
| Device name | Ceruloplasmin, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5210 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for DDB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 222 |
Compare with all 510(k) review times · Search every DDB clearance
Top DDB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kent Laboratories, Inc. | 3 | 1985-11-25 |
| Beckman Instruments, Inc. | 2 | 1997-04-25 |
| Kallestad Laboratories, Inc. | 2 | 1982-11-16 |
| Beckman Coulter Ireland, Inc. | 1 | 2017-01-09 |
| The Binding Site Group , Ltd. | 1 | 2013-06-03 |
10 more applicants have DDB clearances. See the full list in Caduvo.
Most recent DDB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K161508 | Beckman Coulter Ireland, Inc. | Ceruloplasmin | 2017-01-09 | 222 |
| K122965 | The Binding Site Group , Ltd. | HUMAN CAERULOPLASMIN KIT | 2013-06-03 | 252 |
| K053074 | Dade Behring, Inc. | N ANTISERA TO HUMAN CERULOPLASMIN | 2006-03-16 | 135 |
| K964762 | Beckman Instruments, Inc. | IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT | 1997-04-25 | 149 |
| K913668 | The Binding Site, Ltd. | CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT | 1991-12-20 | 123 |
Recalls for DDB devices
openFDA lists no recalls for product code DDB.
Frequently asked questions
What is FDA product code DDB?
DDB is the FDA product code for ceruloplasmin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5210 and reviewed by the Immunology panel.
What device class is DDB?
Class II, regulation 21 CFR 866.5210. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DDB?
Across 19 cleared submissions the average was 99 days from receipt to decision (median 57).
Which companies have the most DDB clearances?
Kent Laboratories, Inc. (3); Beckman Instruments, Inc. (2); Kallestad Laboratories, Inc. (2); Beckman Coulter Ireland, Inc. (1); The Binding Site Group , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DDB
- Run a recall and safety report across every DDB manufacturer
- Watch product code DDB 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 Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times