510(k) K032985

GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM by Hmd Biomedical, Inc. — Product Code NBW

K032985 is an FDA 510(k) premarket notification submitted by Hmd Biomedical, Inc. for the device "GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 21, 2003. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Hmd Biomedical, Inc. has at least 10 other 510(k) clearances on record.