FDA product code GGO: Reagent, Thromboplastin And Control
GGO is the FDA product code for reagent, thromboplastin and control. It is a Class II device, regulated under 21 CFR 864.7925 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under GGO. The average 510(k) review took 64 days (median 64).
Classification
| Field | Value |
|---|---|
| Device name | Reagent, Thromboplastin And Control |
| Device class | Class II |
| Regulation | 21 CFR 864.7925 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GGO clearance
Top GGO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Diagnostics, Inc. | 1 | 2001-03-22 |
Most recent GGO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K010158 | Sigma Diagnostics, Inc. | THROMBOMAX-HS WITH CALCIUM, MODEL T6540 | 2001-03-22 | 64 |
Recalls for GGO devices
openFDA lists no recalls for product code GGO.
Frequently asked questions
What is FDA product code GGO?
GGO is the FDA product code for reagent, thromboplastin and control. It is a Class II device, regulated under 21 CFR 864.7925 and reviewed by the Hematology panel.
What device class is GGO?
Class II, regulation 21 CFR 864.7925. Typical premarket route: 510(k).
How long does a 510(k) take for product code GGO?
Across 1 cleared submissions the average was 64 days from receipt to decision (median 64).
Which companies have the most GGO clearances?
Sigma Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GGO
- Run a recall and safety report across every GGO manufacturer
- Watch product code GGO 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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