510(k) K092506

EASYRA GLU-H REAGENT, MODEL 10200 by Medica Corp. — Product Code CFR

K092506 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "EASYRA GLU-H REAGENT, MODEL 10200". The FDA issued a decision of Substantially Equivalent on September 16, 2009. The device falls under product code CFR (Hexokinase, Glucose), a Class II device regulated under 21 CFR 862.1345. Medica Corp. has at least 10 other 510(k) clearances on record.