510(k) K142336

GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System by Arkray Factory, Inc. — Product Code CGA

K142336 is an FDA 510(k) premarket notification submitted by Arkray Factory, Inc. for the device "GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on September 17, 2014. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Arkray Factory, Inc. has at least 5 other 510(k) clearances on record.