510(k) K894002

CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY by Baxter Healthcare Corp — Product Code LIN

K894002 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY". The FDA issued a decision of Substantially Equivalent on August 10, 1989. The device falls under product code LIN (Antisera, Conjugated Fluorescent, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.