FDA product code GGQ: Test, Prothrombin Consumption
GGQ is the FDA product code for test, prothrombin consumption. It is a Class II device, regulated under 21 CFR 864.7720 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under GGQ. The average 510(k) review took 84 days (median 84).
Classification
| Field | Value |
|---|---|
| Device name | Test, Prothrombin Consumption |
| Device class | Class II |
| Regulation | 21 CFR 864.7720 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GGQ clearance
Top GGQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 2 | 1981-03-17 |
Most recent GGQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K803081 | Abbott Laboratories | QUANTICHECK CONTROL PLASMA | 1981-03-17 | 102 |
| K800656 | Abbott Laboratories | A-GENT QUANTICHROM THROMBIGEN-E | 1980-05-30 | 66 |
Recalls for GGQ devices
openFDA lists no recalls for product code GGQ.
Frequently asked questions
What is FDA product code GGQ?
GGQ is the FDA product code for test, prothrombin consumption. It is a Class II device, regulated under 21 CFR 864.7720 and reviewed by the Hematology panel.
What device class is GGQ?
Class II, regulation 21 CFR 864.7720. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GGQ?
Across 2 cleared submissions the average was 84 days from receipt to decision (median 84).
Which companies have the most GGQ clearances?
Abbott Laboratories (2).
Next steps
- Run an FDA pathway report with predicate devices for product code GGQ
- Run a recall and safety report across every GGQ manufacturer
- Watch product code GGQ 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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