510(k) K100560

EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 by Biotest Medical Corp. — Product Code NBW

K100560 is an FDA 510(k) premarket notification submitted by Biotest Medical Corp. for the device "EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277". The FDA issued a decision of Substantially Equivalent on May 12, 2010. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Biotest Medical Corp. has 7 other 510(k) clearances on record.