FDA product code DMI: Potassium Dichromate Specific Reagent For Alcohol
DMI is the FDA product code for potassium dichromate specific reagent for alcohol. It is a Class II device, regulated under 21 CFR 862.3040 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DMI. The average 510(k) review took 25 days (median 25).
Classification
| Field | Value |
|---|---|
| Device name | Potassium Dichromate Specific Reagent For Alcohol |
| Device class | Class II |
| Regulation | 21 CFR 862.3040 |
| 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 DMI clearance
Top DMI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 1 | 1990-08-17 |
Most recent DMI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K903228 | Syva Co. | EMIT ETS PLUS ETHYL ALCOHOL ASSAY | 1990-08-17 | 25 |
Recalls for DMI devices
openFDA lists no recalls for product code DMI.
Frequently asked questions
What is FDA product code DMI?
DMI is the FDA product code for potassium dichromate specific reagent for alcohol. It is a Class II device, regulated under 21 CFR 862.3040 and reviewed by the Clinical Toxicology panel.
What device class is DMI?
Class II, regulation 21 CFR 862.3040. Typical premarket route: 510(k).
How long does a 510(k) take for product code DMI?
Across 1 cleared submissions the average was 25 days from receipt to decision (median 25).
Which companies have the most DMI clearances?
Syva Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DMI
- Run a recall and safety report across every DMI manufacturer
- Watch product code DMI 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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