FDA product code DOZ: Liquid Chromatography, Diphenylhydantoin
DOZ is the FDA product code for liquid chromatography, diphenylhydantoin. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DOZ. The average 510(k) review took 44 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Liquid Chromatography, Diphenylhydantoin |
| Device class | Class II |
| Regulation | 21 CFR 862.3350 |
| 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 DOZ clearance
Top DOZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 1979-01-03 |
Most recent DOZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K781941 | E.I. Dupont DE Nemours & Co., Inc. | ANALYSIS SYSTEM, PREP SAMPLE | 1979-01-03 | 44 |
Recalls for DOZ devices
openFDA lists no recalls for product code DOZ.
Frequently asked questions
What is FDA product code DOZ?
DOZ is the FDA product code for liquid chromatography, diphenylhydantoin. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel.
What device class is DOZ?
Class II, regulation 21 CFR 862.3350. Typical premarket route: 510(k).
How long does a 510(k) take for product code DOZ?
Across 1 cleared submissions the average was 44 days from receipt to decision (median 44).
Which companies have the most DOZ clearances?
E.I. Dupont DE Nemours & Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DOZ
- Run a recall and safety report across every DOZ manufacturer
- Watch product code DOZ 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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