510(k) K896028

GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600 by American Research Products Co. — Product Code CFR

K896028 is an FDA 510(k) premarket notification submitted by American Research Products Co. for the device "GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600". The FDA issued a decision of Substantially Equivalent on November 14, 1989. The device falls under product code CFR (Hexokinase, Glucose), a Class II device regulated under 21 CFR 862.1345. American Research Products Co. has at least 10 other 510(k) clearances on record.