FDA product code CFB: Chromatographic Derivative, Total Lipids
CFB is the FDA product code for chromatographic derivative, total lipids. It is a Class I device, regulated under 21 CFR 862.1470 and reviewed by the Clinical Chemistry panel. Devices under CFB reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Chromatographic Derivative, Total Lipids |
| Device class | Class I |
| Regulation | 21 CFR 862.1470 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for CFB devices
openFDA lists no recalls for product code CFB.
Frequently asked questions
What is FDA product code CFB?
CFB is the FDA product code for chromatographic derivative, total lipids. It is a Class I device, regulated under 21 CFR 862.1470 and reviewed by the Clinical Chemistry panel.
What device class is CFB?
Class I, regulation 21 CFR 862.1470. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code CFB
- Run a recall and safety report across every CFB manufacturer
- Watch product code CFB 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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