510(k) K070524

MICRODOT BLOOD GLUCOSE MONITORING SYSTEM by Cambridge Sensors Limited — Product Code NBW

K070524 is an FDA 510(k) premarket notification submitted by Cambridge Sensors Limited for the device "MICRODOT BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 22, 2007. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Cambridge Sensors Limited has at least 2 other 510(k) clearances on record.