FDA product code IGD: Solution, Formol Calcium
IGD is the FDA product code for solution, formol calcium. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. Devices under IGD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Solution, Formol Calcium |
| 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 IGD devices
openFDA lists no recalls for product code IGD.
Frequently asked questions
What is FDA product code IGD?
IGD is the FDA product code for solution, formol calcium. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IGD?
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 IGD
- Run a recall and safety report across every IGD manufacturer
- Watch product code IGD 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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