510(k) K761154

GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ by Advanced Biomedical Methods, Inc. — Product Code CGA

K761154 is an FDA 510(k) premarket notification submitted by Advanced Biomedical Methods, Inc. for the device "GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ". The FDA issued a decision of Substantially Equivalent on December 9, 1976. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Advanced Biomedical Methods, Inc. has at least 10 other 510(k) clearances on record.