510(k) K800656

A-GENT QUANTICHROM THROMBIGEN-E by Abbott Laboratories — Product Code GGQ

K800656 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "A-GENT QUANTICHROM THROMBIGEN-E". The FDA issued a decision of Substantially Equivalent on May 30, 1980. The device falls under product code GGQ (Test, Prothrombin Consumption), a Class II device regulated under 21 CFR 864.7720. Abbott Laboratories has at least 10 other 510(k) clearances on record.