FDA product code DMN: Thin Layer Chromatography, Cocaine
DMN is the FDA product code for thin layer chromatography, cocaine. It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under DMN, from 2 different applicants. The average 510(k) review took 248 days (median 248).
Classification
| Field | Value |
|---|---|
| Device name | Thin Layer Chromatography, Cocaine |
| Device class | Class II |
| Regulation | 21 CFR 862.3250 |
| 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 DMN clearance
Top DMN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Phamatech | 1 | 1997-08-08 |
| Sakers, Inc. | 1 | 1989-02-07 |
Most recent DMN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972618 | Phamatech | QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070) | 1997-08-08 | 28 |
| K874389 | Sakers, Inc. | CRACK-IT CHAP SCREEN | 1989-02-07 | 469 |
Recalls for DMN devices
openFDA lists no recalls for product code DMN.
Frequently asked questions
What is FDA product code DMN?
DMN is the FDA product code for thin layer chromatography, cocaine. It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel.
What device class is DMN?
Class II, regulation 21 CFR 862.3250. Typical premarket route: 510(k).
How long does a 510(k) take for product code DMN?
Across 2 cleared submissions the average was 248 days from receipt to decision (median 248).
Which companies have the most DMN clearances?
Phamatech (1); Sakers, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DMN
- Run a recall and safety report across every DMN manufacturer
- Watch product code DMN 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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