FDA product code GGZ: Oxyhemoglobin
GGZ is the FDA product code for oxyhemoglobin. It is a Class II device, regulated under 21 CFR 864.7500 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under GGZ. The average 510(k) review took 140 days (median 140).
Classification
| Field | Value |
|---|---|
| Device name | Oxyhemoglobin |
| Device class | Class II |
| Regulation | 21 CFR 864.7500 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GGZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 212 |
| 2020 | 1 | 69 |
Top GGZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nova Biomedical Corporation | 2 | 2020-04-06 |
Most recent GGZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200204 | Nova Biomedical Corporation | Stat Profile Prime Plus Analyzer System | 2020-04-06 | 69 |
| K180186 | Nova Biomedical Corporation | Stat Profile Prime Plus Analyzer System | 2018-08-23 | 212 |
Recalls for GGZ devices
openFDA lists no recalls for product code GGZ.
Frequently asked questions
What is FDA product code GGZ?
GGZ is the FDA product code for oxyhemoglobin. It is a Class II device, regulated under 21 CFR 864.7500 and reviewed by the Hematology panel.
What device class is GGZ?
Class II, regulation 21 CFR 864.7500. Typical premarket route: 510(k).
How long does a 510(k) take for product code GGZ?
Across 2 cleared submissions the average was 140 days from receipt to decision (median 140).
Which companies have the most GGZ clearances?
Nova Biomedical Corporation (2).
Next steps
- Run an FDA pathway report with predicate devices for product code GGZ
- Run a recall and safety report across every GGZ manufacturer
- Watch product code GGZ 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.