510(k) K831628

CREATININE REAGENTS B6370-13 by American Scientific Products — Product Code CGX

K831628 is an FDA 510(k) premarket notification submitted by American Scientific Products for the device "CREATININE REAGENTS B6370-13". The FDA issued a decision of Substantially Equivalent on July 6, 1983. The device falls under product code CGX (Alkaline Picrate, Colorimetry, Creatinine), a Class II device regulated under 21 CFR 862.1225. American Scientific Products has at least 10 other 510(k) clearances on record.