510(k) K073390

DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS by DiaSorin, Inc. — Product Code LFX

K073390 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS". The FDA issued a decision of Substantially Equivalent on November 21, 2008. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.