510(k) K040120

DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS by DiaSorin, Inc. — Product Code LLM

K040120 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS". The FDA issued a decision of Substantially Equivalent on April 29, 2005. The device falls under product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.