510(k) K830118

ALKALINE PHOSPHATES ISOENZYME SUBSTRATE by Corning Medical & Scientific — Product Code CIN

K830118 is an FDA 510(k) premarket notification submitted by Corning Medical & Scientific for the device "ALKALINE PHOSPHATES ISOENZYME SUBSTRATE". The FDA issued a decision of Substantially Equivalent on February 25, 1983. The device falls under product code CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Corning Medical & Scientific has at least 10 other 510(k) clearances on record.