510(k) K081609

CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237 by Taidoc Technology Corporation — Product Code CGA

K081609 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237". The FDA issued a decision of Substantially Equivalent on Jul 2, 2008. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Taidoc Technology Corporation has 122 other 510(k) clearances on record.