510(k) K121433

GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS by Hmd Biomedical, Inc. — Product Code LFR

K121433 is an FDA 510(k) premarket notification submitted by Hmd Biomedical, Inc. for the device "GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS". The FDA issued a decision of Substantially Equivalent on February 14, 2013. The device falls under product code LFR (Glucose Dehydrogenase, Glucose), a Class II device regulated under 21 CFR 862.1345. Hmd Biomedical, Inc. has at least 10 other 510(k) clearances on record.