510(k) K142785

PRODIGY iConnect Blood Glucose Monitoring System by Ok Biotech Co., Ltd. — Product Code NBW

K142785 is an FDA 510(k) premarket notification submitted by Ok Biotech Co., Ltd. for the device "PRODIGY iConnect Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on December 17, 2015. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Ok Biotech Co., Ltd. has at least 8 other 510(k) clearances on record.