FDA product code GGF: Acid Hematin
GGF is the FDA product code for acid hematin. It is a Class II device, regulated under 21 CFR 864.7500 and reviewed by the Hematology panel. Devices under GGF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Acid Hematin |
| Device class | Class II |
| Regulation | 21 CFR 864.7500 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Recalls for GGF devices
openFDA lists no recalls for product code GGF.
Frequently asked questions
What is FDA product code GGF?
GGF is the FDA product code for acid hematin. It is a Class II device, regulated under 21 CFR 864.7500 and reviewed by the Hematology panel.
What device class is GGF?
Class II, regulation 21 CFR 864.7500. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GGF
- Run a recall and safety report across every GGF manufacturer
- Watch product code GGF 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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