FDA product code DJH: Gas Chromatography, Phenobarbital
DJH is the FDA product code for gas chromatography, phenobarbital. It is a Class II device, regulated under 21 CFR 862.3660 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DJH. The average 510(k) review took 0 days (median 0).
Classification
| Field | Value |
|---|---|
| Device name | Gas Chromatography, Phenobarbital |
| Device class | Class II |
| Regulation | 21 CFR 862.3660 |
| 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 DJH clearance
Top DJH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Elema AB | 1 | 1984-09-04 |
Most recent DJH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K843440 | Siemens Elema AB | MINGO LOG 7 | 1984-09-04 | 0 |
Recalls for DJH devices
openFDA lists no recalls for product code DJH.
Frequently asked questions
What is FDA product code DJH?
DJH is the FDA product code for gas chromatography, phenobarbital. It is a Class II device, regulated under 21 CFR 862.3660 and reviewed by the Clinical Toxicology panel.
What device class is DJH?
Class II, regulation 21 CFR 862.3660. Typical premarket route: 510(k).
How long does a 510(k) take for product code DJH?
Across 1 cleared submissions the average was 0 days from receipt to decision (median 0).
Which companies have the most DJH clearances?
Siemens Elema AB (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DJH
- Run a recall and safety report across every DJH manufacturer
- Watch product code DJH 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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