FDA product code IGK: Solution, Clarke'S
IGK is the FDA product code for solution, clarke's. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Hematology panel. Devices under IGK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Solution, Clarke'S |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | HE — Hematology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for IGK devices
openFDA lists no recalls for product code IGK.
Frequently asked questions
What is FDA product code IGK?
IGK is the FDA product code for solution, clarke's. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Hematology panel.
What device class is IGK?
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 IGK
- Run a recall and safety report across every IGK manufacturer
- Watch product code IGK 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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