FDA product code DOR: Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep.
DOR is the FDA product code for radioimmunoassay, digoxin (3-h), bovine antibody, charcoal sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DOR. The average 510(k) review took 68 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep. |
| Device class | Class II |
| Regulation | 21 CFR 862.3320 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DOR clearance
Top DOR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stanco Medical, Inc. | 1 | 1980-11-26 |
Most recent DOR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K802289 | Stanco Medical, Inc. | PERICARDIOCENTESIS KIT | 1980-11-26 | 68 |
Recalls for DOR devices
openFDA lists no recalls for product code DOR.
Frequently asked questions
What is FDA product code DOR?
DOR is the FDA product code for radioimmunoassay, digoxin (3-h), bovine antibody, charcoal sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel.
What device class is DOR?
Class II, regulation 21 CFR 862.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code DOR?
Across 1 cleared submissions the average was 68 days from receipt to decision (median 68).
Which companies have the most DOR clearances?
Stanco Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DOR
- Run a recall and safety report across every DOR manufacturer
- Watch product code DOR 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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