510(k) K033055

GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS by Diamond Diagnostics, Inc. — Product Code CGA

K033055 is an FDA 510(k) premarket notification submitted by Diamond Diagnostics, Inc. for the device "GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS". The FDA issued a decision of Substantially Equivalent on January 30, 2004. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Diamond Diagnostics, Inc. has at least 10 other 510(k) clearances on record.