510(k) K041427

THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS by Arkray, Inc. — Product Code CGA

K041427 is an FDA 510(k) premarket notification submitted by Arkray, Inc. for the device "THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS". The FDA issued a decision of Substantially Equivalent on November 24, 2004. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Arkray, Inc. has at least 10 other 510(k) clearances on record.