510(k) K982533

UNICAP GLIADIN IGA ASSAY by Pharmacia & Upjohn Co. — Product Code MST

K982533 is an FDA 510(k) premarket notification submitted by Pharmacia & Upjohn Co. for the device "UNICAP GLIADIN IGA ASSAY". The FDA issued a decision of Substantially Equivalent on October 22, 1998. The device falls under product code MST (Antibodies, Gliadin), a Class II device regulated under 21 CFR 866.5750. Pharmacia & Upjohn Co. has at least 10 other 510(k) clearances on record.