FDA product code DDF: Prothrombin, Antigen, Antiserum, Control
DDF is the FDA product code for prothrombin, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5735 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under DDF, from 2 different applicants. The average 510(k) review took 79 days (median 79).
Classification
| Field | Value |
|---|---|
| Device name | Prothrombin, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5735 |
| Review panel | HE — Hematology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DDF clearance
Top DDF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Organon Teknika Corp. | 1 | 1991-05-15 |
| Hoffmann-La Roche, Inc. | 1 | 1981-12-31 |
Most recent DDF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K910617 | Organon Teknika Corp. | NATIVE PROTHROMBIN ANTIGEN EIA | 1991-05-15 | 92 |
| K812985 | Hoffmann-La Roche, Inc. | AGGLUTEX MORPHINE TEST KIT | 1981-12-31 | 66 |
Recalls for DDF devices
openFDA lists no recalls for product code DDF.
Frequently asked questions
What is FDA product code DDF?
DDF is the FDA product code for prothrombin, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5735 and reviewed by the Hematology panel.
What device class is DDF?
Class I, regulation 21 CFR 866.5735. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DDF?
Across 2 cleared submissions the average was 79 days from receipt to decision (median 79).
Which companies have the most DDF clearances?
Organon Teknika Corp. (1); Hoffmann-La Roche, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DDF
- Run a recall and safety report across every DDF manufacturer
- Watch product code DDF 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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