FDA product code DKH: Gas Chromatography, Diphenylhydantoin
DKH is the FDA product code for gas chromatography, diphenylhydantoin. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under DKH, from 2 different applicants. The average 510(k) review took 37 days (median 37).
Classification
| Field | Value |
|---|---|
| Device name | Gas 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 DKH clearance
Top DKH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 1980-06-20 |
| Vitek Systems, Inc. | 1 | 1978-06-22 |
Most recent DKH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K801276 | E.I. Dupont DE Nemours & Co., Inc. | DUPONT PREP APPLI. FOR PHENOBARBITAL, | 1980-06-20 | 23 |
| K780733 | Vitek Systems, Inc. | ANTICONVULSANTS III CALIBRATOR KIT | 1978-06-22 | 51 |
Recalls for DKH devices
openFDA lists no recalls for product code DKH.
Frequently asked questions
What is FDA product code DKH?
DKH is the FDA product code for gas 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 DKH?
Class II, regulation 21 CFR 862.3350. Typical premarket route: 510(k).
How long does a 510(k) take for product code DKH?
Across 2 cleared submissions the average was 37 days from receipt to decision (median 37).
Which companies have the most DKH clearances?
E.I. Dupont DE Nemours & Co., Inc. (1); Vitek Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DKH
- Run a recall and safety report across every DKH manufacturer
- Watch product code DKH 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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