510(k) K123586

EASYRA CREATININE REAGENT by Medica Corporation — Product Code CGX

K123586 is an FDA 510(k) premarket notification submitted by Medica Corporation for the device "EASYRA CREATININE REAGENT". The FDA issued a decision of Substantially Equivalent on May 15, 2013. The device falls under product code CGX (Alkaline Picrate, Colorimetry, Creatinine), a Class II device regulated under 21 CFR 862.1225. Medica Corporation has at least 6 other 510(k) clearances on record.