510(k) K080823

EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT by Medica Corp. — Product Code JFJ

K080823 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT". The FDA issued a decision of Substantially Equivalent on November 17, 2008. The device falls under product code JFJ (Catalytic Methods, Amylase), a Class II device regulated under 21 CFR 862.1070. Medica Corp. has at least 10 other 510(k) clearances on record.