Product code GGQ— Hematology
A-GENT QUANTICHROM THROMBIGEN-E
- Classification name
- Test, Prothrombin Consumption
- Device class
- Class 2
- Regulation
- 21 CFR 864.7720
- Advisory panel
- Hematology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code GGQ
FDA has cleared devices under product code GGQ between 1980 and 1981, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1981
- 1980
Top applicants under product code GGQ
Recent clearances under product code GGQ
Data sourced from openFDA. This site is unofficial and independent of the FDA.