510(k) K092603

COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY by Roche Diagnostics — Product Code CFR

K092603 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY". The FDA issued a decision of Substantially Equivalent on December 4, 2009. The device falls under product code CFR (Hexokinase, Glucose), a Class II device regulated under 21 CFR 862.1345. Roche Diagnostics has at least 10 other 510(k) clearances on record.