510(k) K123802

EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT by Medica Corp. — Product Code CIG

K123802 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT". The FDA issued a decision of Substantially Equivalent on March 1, 2013. 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.