510(k) K833318

NORMAL GOAT SERUM by Biosan Laboratories, Inc. — Product Code DHX

K833318 is an FDA 510(k) premarket notification submitted by Biosan Laboratories, Inc. for the device "NORMAL GOAT SERUM". The FDA issued a decision of Substantially Equivalent on January 3, 1984. The device falls under product code DHX (System, Test, Carcinoembryonic Antigen), a Class II device regulated under 21 CFR 866.6010. Biosan Laboratories, Inc. has at least 9 other 510(k) clearances on record.