510(k) K811406

CREATININE RATE REAGENT KIT by Chem-Elec, Inc. — Product Code CGX

K811406 is an FDA 510(k) premarket notification submitted by Chem-Elec, Inc. for the device "CREATININE RATE REAGENT KIT". The FDA issued a decision of Substantially Equivalent on August 13, 1981. The device falls under product code CGX (Alkaline Picrate, Colorimetry, Creatinine), a Class II device regulated under 21 CFR 862.1225. Chem-Elec, Inc. has at least 8 other 510(k) clearances on record.