510(k) K201037

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System by Taidoc Technology Corporation — Product Code NBW

K201037 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System". The FDA issued a decision of Substantially Equivalent on June 16, 2022. 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.