FDA product code GHZ: Solution, Gugol Blue
GHZ is the FDA product code for solution, gugol blue. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. Devices under GHZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Solution, Gugol Blue |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for GHZ devices
openFDA lists no recalls for product code GHZ.
Frequently asked questions
What is FDA product code GHZ?
GHZ is the FDA product code for solution, gugol blue. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is GHZ?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GHZ
- Run a recall and safety report across every GHZ manufacturer
- Watch product code GHZ 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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