510(k) K100187

EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT by Medica Corp. — Product Code CGA

K100187 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT". The FDA issued a decision of Substantially Equivalent on May 5, 2010. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Medica Corp. has at least 10 other 510(k) clearances on record.