FDA product code DMB: Gas Chromatography, Methadone
DMB is the FDA product code for gas chromatography, methadone. It is a Class II device, regulated under 21 CFR 862.3620 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DMB. The average 510(k) review took 47 days (median 47).
Classification
| Field | Value |
|---|---|
| Device name | Gas Chromatography, Methadone |
| Device class | Class II |
| Regulation | 21 CFR 862.3620 |
| 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 DMB clearance
Top DMB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 1 | 1991-09-16 |
Most recent DMB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K913410 | Syva Co. | EMIT(R) 2000 GENTAMICIN ASSAY/CALIBRATORS | 1991-09-16 | 47 |
Recalls for DMB devices
openFDA lists no recalls for product code DMB.
Frequently asked questions
What is FDA product code DMB?
DMB is the FDA product code for gas chromatography, methadone. It is a Class II device, regulated under 21 CFR 862.3620 and reviewed by the Clinical Toxicology panel.
What device class is DMB?
Class II, regulation 21 CFR 862.3620. Typical premarket route: 510(k).
How long does a 510(k) take for product code DMB?
Across 1 cleared submissions the average was 47 days from receipt to decision (median 47).
Which companies have the most DMB clearances?
Syva Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DMB
- Run a recall and safety report across every DMB manufacturer
- Watch product code DMB 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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