510(k) K831634

GLUCOSE REAGENT B6360-11 by American Scientific Products — Product Code CGA

K831634 is an FDA 510(k) premarket notification submitted by American Scientific Products for the device "GLUCOSE REAGENT B6360-11". The FDA issued a decision of Substantially Equivalent on July 19, 1983. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. American Scientific Products has at least 10 other 510(k) clearances on record.