FDA product code GJN: Fluid, Diluting, Red-Cell
GJN is the FDA product code for fluid, diluting, red-cell. It is a Class I device, regulated under 21 CFR 864.8200 and reviewed by the Hematology panel. Devices under GJN reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Fluid, Diluting, Red-Cell |
| Device class | Class I |
| Regulation | 21 CFR 864.8200 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Recalls for GJN devices
openFDA lists no recalls for product code GJN.
Frequently asked questions
What is FDA product code GJN?
GJN is the FDA product code for fluid, diluting, red-cell. It is a Class I device, regulated under 21 CFR 864.8200 and reviewed by the Hematology panel.
What device class is GJN?
Class I, regulation 21 CFR 864.8200. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GJN
- Run a recall and safety report across every GJN manufacturer
- Watch product code GJN 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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