FDA product code KDY: Agent, Chelating For Decalcification
KDY is the FDA product code for agent, chelating for decalcification. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. Devices under KDY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Agent, Chelating For Decalcification |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for KDY devices
openFDA lists no recalls for product code KDY.
Frequently asked questions
What is FDA product code KDY?
KDY is the FDA product code for agent, chelating for decalcification. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is KDY?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KDY
- Run a recall and safety report across every KDY manufacturer
- Watch product code KDY 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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