510(k) K010039

QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION by Chronimed, Inc. — Product Code NBW

K010039 is an FDA 510(k) premarket notification submitted by Chronimed, Inc. for the device "QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION". The FDA issued a decision of Substantially Equivalent on August 10, 2001. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Chronimed, Inc. has at least 4 other 510(k) clearances on record.