510(k) K931939

OLYMPUS CREATININE REAGENT by Olympus Corp. — Product Code CGX

K931939 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "OLYMPUS CREATININE REAGENT". The FDA issued a decision of Substantially Equivalent on September 21, 1993. The device falls under product code CGX (Alkaline Picrate, Colorimetry, Creatinine), a Class II device regulated under 21 CFR 862.1225. Olympus Corp. has at least 10 other 510(k) clearances on record.