FDA product code CEA: Tlc Chromatographic Separation Triglycerides
CEA is the FDA product code for tlc chromatographic separation triglycerides. It is a Class I device, regulated under 21 CFR 862.1705 and reviewed by the Clinical Chemistry panel. Devices under CEA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Tlc Chromatographic Separation Triglycerides |
| Device class | Class I |
| Regulation | 21 CFR 862.1705 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for CEA devices
openFDA lists no recalls for product code CEA.
Frequently asked questions
What is FDA product code CEA?
CEA is the FDA product code for tlc chromatographic separation triglycerides. It is a Class I device, regulated under 21 CFR 862.1705 and reviewed by the Clinical Chemistry panel.
What device class is CEA?
Class I, regulation 21 CFR 862.1705. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code CEA
- Run a recall and safety report across every CEA manufacturer
- Watch product code CEA 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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