510(k) K122525

SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM by Biotest Medical Corp. — Product Code NBW

K122525 is an FDA 510(k) premarket notification submitted by Biotest Medical Corp. for the device "SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 2, 2013. 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.