FDA product code GHA: Hemoglobin, Alkali Resistant
GHA is the FDA product code for hemoglobin, alkali resistant. It is a Class II device, regulated under 21 CFR 864.7455 and reviewed by the Hematology panel. Devices under GHA reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Hemoglobin, Alkali Resistant |
| Device class | Class II |
| Regulation | 21 CFR 864.7455 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for GHA devices
openFDA lists no recalls for product code GHA.
Frequently asked questions
What is FDA product code GHA?
GHA is the FDA product code for hemoglobin, alkali resistant. It is a Class II device, regulated under 21 CFR 864.7455 and reviewed by the Hematology panel.
What device class is GHA?
Class II, regulation 21 CFR 864.7455. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code GHA
- Run a recall and safety report across every GHA manufacturer
- Watch product code GHA 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.