510(k) K901840

(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM by Granbio, Inc. — Product Code LJN

K901840 is an FDA 510(k) premarket notification submitted by Granbio, Inc. for the device "(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM". The FDA issued a decision of Substantially Equivalent on September 12, 1990. The device falls under product code LJN (Antibody Igm, If, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Granbio, Inc. has at least 7 other 510(k) clearances on record.