FDA product code CIK: Radial Diffusion, Amylase
CIK is the FDA product code for radial diffusion, amylase. It is a Class II device, regulated under 21 CFR 862.1070 and reviewed by the Clinical Chemistry panel. Devices under CIK reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Radial Diffusion, Amylase |
| Device class | Class II |
| Regulation | 21 CFR 862.1070 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for CIK devices
openFDA lists no recalls for product code CIK.
Frequently asked questions
What is FDA product code CIK?
CIK is the FDA product code for radial diffusion, amylase. It is a Class II device, regulated under 21 CFR 862.1070 and reviewed by the Clinical Chemistry panel.
What device class is CIK?
Class II, regulation 21 CFR 862.1070. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code CIK
- Run a recall and safety report across every CIK manufacturer
- Watch product code CIK 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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