510(k) K091991

EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 by Medica Corp. — Product Code CIG

K091991 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200". The FDA issued a decision of Substantially Equivalent on September 4, 2009. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Medica Corp. has at least 10 other 510(k) clearances on record.