510(k) K080810

EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT by Medica Corp. — Product Code CIG

K080810 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT". The FDA issued a decision of Substantially Equivalent on December 10, 2008. 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.