510(k) K864877

TRI-LEVEL LIGAND CONTROL by Ciba Corning Diagnostics Corp. — Product Code DHX

K864877 is an FDA 510(k) premarket notification submitted by Ciba Corning Diagnostics Corp. for the device "TRI-LEVEL LIGAND CONTROL". The FDA issued a decision of Substantially Equivalent on May 21, 1987. The device falls under product code DHX (System, Test, Carcinoembryonic Antigen), a Class II device regulated under 21 CFR 866.6010. Ciba Corning Diagnostics Corp. has at least 10 other 510(k) clearances on record.