FDA product code CGD: Ferricyanide, Glucose
CGD is the FDA product code for ferricyanide, glucose. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel. Devices under CGD reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Ferricyanide, 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 CGD devices
openFDA lists no recalls for product code CGD.
Frequently asked questions
What is FDA product code CGD?
CGD is the FDA product code for ferricyanide, glucose. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel.
What device class is CGD?
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 CGD
- Run a recall and safety report across every CGD manufacturer
- Watch product code CGD 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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