FDA product code GHK: Centrifuge, Microsedimentation
GHK is the FDA product code for centrifuge, microsedimentation. It is a Class I device, regulated under 21 CFR 864.5350 and reviewed by the Hematology panel. Devices under GHK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Centrifuge, Microsedimentation |
| Device class | Class I |
| Regulation | 21 CFR 864.5350 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Recalls for GHK devices
openFDA lists no recalls for product code GHK.
Frequently asked questions
What is FDA product code GHK?
GHK is the FDA product code for centrifuge, microsedimentation. It is a Class I device, regulated under 21 CFR 864.5350 and reviewed by the Hematology panel.
What device class is GHK?
Class I, regulation 21 CFR 864.5350. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GHK
- Run a recall and safety report across every GHK manufacturer
- Watch product code GHK 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.