510(k) K170316

ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM by Abbott Laboratories — Product Code CFR

K170316 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM". The FDA issued a decision of Substantially Equivalent on October 19, 2017. The device falls under product code CFR (Hexokinase, Glucose), a Class II device regulated under 21 CFR 862.1345. Abbott Laboratories has at least 10 other 510(k) clearances on record.