510(k) K090628

DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 by Bayer Healthcare, LLC — Product Code NBW

K090628 is an FDA 510(k) premarket notification submitted by Bayer Healthcare, LLC for the device "DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080". The FDA issued a decision of Substantially Equivalent on December 4, 2009. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Bayer Healthcare, LLC has at least 10 other 510(k) clearances on record.