FDA product code DOH: Electrometry, Cholinesterase
DOH is the FDA product code for electrometry, cholinesterase. It is a Class I device, regulated under 21 CFR 862.3240 and reviewed by the Clinical Toxicology panel. Devices under DOH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Electrometry, Cholinesterase |
| Device class | Class I |
| Regulation | 21 CFR 862.3240 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Recalls for DOH devices
openFDA lists no recalls for product code DOH.
Frequently asked questions
What is FDA product code DOH?
DOH is the FDA product code for electrometry, cholinesterase. It is a Class I device, regulated under 21 CFR 862.3240 and reviewed by the Clinical Toxicology panel.
What device class is DOH?
Class I, regulation 21 CFR 862.3240. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DOH
- Run a recall and safety report across every DOH manufacturer
- Watch product code DOH 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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