510(k) K113768

U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM by Taidoc Technology Corporation — Product Code LFR

K113768 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on April 12, 2012. The device falls under product code LFR (Glucose Dehydrogenase, Glucose), a Class II device regulated under 21 CFR 862.1345. Taidoc Technology Corporation has at least 10 other 510(k) clearances on record.