510(k) K812109

GILCHEM CREATININE REAGENT by Gilford Diagnostics — Product Code CGX

K812109 is an FDA 510(k) premarket notification submitted by Gilford Diagnostics for the device "GILCHEM CREATININE REAGENT". 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. Gilford Diagnostics has at least 10 other 510(k) clearances on record.