FDA product code GGY: Pipette, Diluting
GGY is the FDA product code for pipette, diluting. It is a Class I device, regulated under 21 CFR 864.6160 and reviewed by the Hematology panel. Devices under GGY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Pipette, Diluting |
| Device class | Class I |
| Regulation | 21 CFR 864.6160 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Recalls for GGY devices
openFDA lists no recalls for product code GGY.
Frequently asked questions
What is FDA product code GGY?
GGY is the FDA product code for pipette, diluting. It is a Class I device, regulated under 21 CFR 864.6160 and reviewed by the Hematology panel.
What device class is GGY?
Class I, regulation 21 CFR 864.6160. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GGY
- Run a recall and safety report across every GGY manufacturer
- Watch product code GGY 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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