FDA product code GKE: Osmotic Fragility Testing
GKE is the FDA product code for osmotic fragility testing. It is a Class I device, regulated under 21 CFR 864.6600 and reviewed by the Hematology panel. Devices under GKE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for GKE devices.
Classification
| Field | Value |
|---|---|
| Device name | Osmotic Fragility Testing |
| Device class | Class I |
| Regulation | 21 CFR 864.6600 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Recalls for GKE devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-01-19.
Frequently asked questions
What is FDA product code GKE?
GKE is the FDA product code for osmotic fragility testing. It is a Class I device, regulated under 21 CFR 864.6600 and reviewed by the Hematology panel.
What device class is GKE?
Class I, regulation 21 CFR 864.6600. Typical premarket route: 510(k) exempt.
Have GKE devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2011-01-19.
Next steps
- Run an FDA pathway report with predicate devices for product code GKE
- Run a recall and safety report across every GKE manufacturer
- Watch product code GKE 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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