510(k) K101854

ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 by Siemens Healthcare Diagnostics — Product Code CFR

K101854 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429". The FDA issued a decision of Substantially Equivalent on March 7, 2011. The device falls under product code CFR (Hexokinase, Glucose), a Class II device regulated under 21 CFR 862.1345. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.