510(k) K183306

GLUCOCARD® W onyx Blood Glucose Monitoring System by Arkray Factory, Inc. — Product Code NBW

K183306 is an FDA 510(k) premarket notification submitted by Arkray Factory, Inc. for the device "GLUCOCARD® W onyx Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on April 10, 2019. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Arkray Factory, Inc. has at least 5 other 510(k) clearances on record.