FDA product code CDK: Acid, Vanilmandelic, Electrophoretic Separation
CDK is the FDA product code for acid, vanilmandelic, electrophoretic separation. It is a Class I device, regulated under 21 CFR 862.1795 and reviewed by the Clinical Chemistry panel. Devices under CDK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Acid, Vanilmandelic, Electrophoretic Separation |
| Device class | Class I |
| Regulation | 21 CFR 862.1795 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for CDK devices
openFDA lists no recalls for product code CDK.
Frequently asked questions
What is FDA product code CDK?
CDK is the FDA product code for acid, vanilmandelic, electrophoretic separation. It is a Class I device, regulated under 21 CFR 862.1795 and reviewed by the Clinical Chemistry panel.
What device class is CDK?
Class I, regulation 21 CFR 862.1795. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code CDK
- Run a recall and safety report across every CDK manufacturer
- Watch product code CDK 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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