FDA product code DMY: Gas Chromatography, Morphine
DMY is the FDA product code for gas chromatography, morphine. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DMY. The average 510(k) review took 65 days (median 65).
Classification
| Field | Value |
|---|---|
| Device name | Gas Chromatography, Morphine |
| Device class | Class II |
| Regulation | 21 CFR 862.3640 |
| 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 DMY clearance
Top DMY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostics Corp. | 1 | 1999-04-15 |
Most recent DMY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K990409 | Roche Diagnostics Corp. | ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) | 1999-04-15 | 65 |
Recalls for DMY devices
openFDA lists no recalls for product code DMY.
Frequently asked questions
What is FDA product code DMY?
DMY is the FDA product code for gas chromatography, morphine. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel.
What device class is DMY?
Class II, regulation 21 CFR 862.3640. Typical premarket route: 510(k).
How long does a 510(k) take for product code DMY?
Across 1 cleared submissions the average was 65 days from receipt to decision (median 65).
Which companies have the most DMY clearances?
Roche Diagnostics Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DMY
- Run a recall and safety report across every DMY manufacturer
- Watch product code DMY 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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