510(k) K161738

FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems by Taidoc Technology Corporation — Product Code NBW

K161738 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems". The FDA issued a decision of Substantially Equivalent on November 10, 2016. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Taidoc Technology Corporation has at least 10 other 510(k) clearances on record.