FDA product code CFW: Copper Reduction, Glucose
CFW is the FDA product code for copper reduction, glucose. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel. Devices under CFW reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Copper Reduction, Glucose |
| Device class | Class II |
| Regulation | 21 CFR 862.1345 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for CFW devices
openFDA lists no recalls for product code CFW.
Frequently asked questions
What is FDA product code CFW?
CFW is the FDA product code for copper reduction, glucose. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel.
What device class is CFW?
Class II, regulation 21 CFR 862.1345. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code CFW
- Run a recall and safety report across every CFW manufacturer
- Watch product code CFW 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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