FDA product code DIR: Free Radical Assay, Cocaine
DIR is the FDA product code for free radical assay, cocaine. It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DIR. The average 510(k) review took 30 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Free Radical Assay, Cocaine |
| Device class | Class II |
| Regulation | 21 CFR 862.3250 |
| 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 DIR clearance
Top DIR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 1986-11-05 |
Most recent DIR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863888 | E.I. Dupont DE Nemours & Co., Inc. | DU PONT PHENYTOIN ASSAY AND CALIBRATOR | 1986-11-05 | 30 |
Recalls for DIR devices
openFDA lists no recalls for product code DIR.
Frequently asked questions
What is FDA product code DIR?
DIR is the FDA product code for free radical assay, cocaine. It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel.
What device class is DIR?
Class II, regulation 21 CFR 862.3250. Typical premarket route: 510(k).
How long does a 510(k) take for product code DIR?
Across 1 cleared submissions the average was 30 days from receipt to decision (median 30).
Which companies have the most DIR clearances?
E.I. Dupont DE Nemours & Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DIR
- Run a recall and safety report across every DIR manufacturer
- Watch product code DIR 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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