FDA product code DOD: Gas Chromatography, Amphetamine
DOD is the FDA product code for gas chromatography, amphetamine. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DOD. The average 510(k) review took 88 days (median 88).
Classification
| Field | Value |
|---|---|
| Device name | Gas Chromatography, Amphetamine |
| Device class | Class II |
| Regulation | 21 CFR 862.3100 |
| 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 DOD clearance
Top DOD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Bio Medica Corp. | 1 | 1999-10-18 |
Most recent DOD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K992452 | American Bio Medica Corp. | RAPIDONE-AMPHETAMINE TEST | 1999-10-18 | 88 |
Recalls for DOD devices
openFDA lists no recalls for product code DOD.
Frequently asked questions
What is FDA product code DOD?
DOD is the FDA product code for gas chromatography, amphetamine. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Clinical Toxicology panel.
What device class is DOD?
Class II, regulation 21 CFR 862.3100. Typical premarket route: 510(k).
How long does a 510(k) take for product code DOD?
Across 1 cleared submissions the average was 88 days from receipt to decision (median 88).
Which companies have the most DOD clearances?
American Bio Medica Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DOD
- Run a recall and safety report across every DOD manufacturer
- Watch product code DOD 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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