FDA product code CGH: Electrophoretic, Globulin
CGH is the FDA product code for electrophoretic, globulin. It is a Class I device, regulated under 21 CFR 862.1330 and reviewed by the Clinical Chemistry panel. Devices under CGH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Electrophoretic, Globulin |
| Device class | Class I |
| Regulation | 21 CFR 862.1330 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for CGH devices
openFDA lists no recalls for product code CGH.
Frequently asked questions
What is FDA product code CGH?
CGH is the FDA product code for electrophoretic, globulin. It is a Class I device, regulated under 21 CFR 862.1330 and reviewed by the Clinical Chemistry panel.
What device class is CGH?
Class I, regulation 21 CFR 862.1330. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code CGH
- Run a recall and safety report across every CGH manufacturer
- Watch product code CGH 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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