FDA product code DMR: Solution, M-Nitrophenol, Specific Reagent For Cholinesterase
DMR is the FDA product code for solution, m-nitrophenol, specific reagent for cholinesterase. It is a Class I device, regulated under 21 CFR 862.3240 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DMR. The average 510(k) review took 34 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Solution, M-Nitrophenol, Specific Reagent For Cholinesterase |
| Device class | Class I |
| Regulation | 21 CFR 862.3240 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DMR clearance
Top DMR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wampole Laboratories | 1 | 1979-06-28 |
Most recent DMR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K790986 | Wampole Laboratories | RF CONTROLS | 1979-06-28 | 34 |
Recalls for DMR devices
openFDA lists no recalls for product code DMR.
Frequently asked questions
What is FDA product code DMR?
DMR is the FDA product code for solution, m-nitrophenol, specific reagent for cholinesterase. It is a Class I device, regulated under 21 CFR 862.3240 and reviewed by the Clinical Toxicology panel.
What device class is DMR?
Class I, regulation 21 CFR 862.3240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DMR?
Across 1 cleared submissions the average was 34 days from receipt to decision (median 34).
Which companies have the most DMR clearances?
Wampole Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DMR
- Run a recall and safety report across every DMR manufacturer
- Watch product code DMR 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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