FDA product code GKW: Aggregometer, Platelet, Thrombokinetogram
GKW is the FDA product code for aggregometer, platelet, thrombokinetogram. It is a Class II device, regulated under 21 CFR 864.6675 and reviewed by the Hematology panel. Devices under GKW reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Aggregometer, Platelet, Thrombokinetogram |
| Device class | Class II |
| Regulation | 21 CFR 864.6675 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for GKW devices
openFDA lists no recalls for product code GKW.
Frequently asked questions
What is FDA product code GKW?
GKW is the FDA product code for aggregometer, platelet, thrombokinetogram. It is a Class II device, regulated under 21 CFR 864.6675 and reviewed by the Hematology panel.
What device class is GKW?
Class II, regulation 21 CFR 864.6675. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code GKW
- Run a recall and safety report across every GKW manufacturer
- Watch product code GKW 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.