510(k) K233605

ADVIA Centaur EBV-EBNA IgG by Biokit, S.A. — Product Code LLM

K233605 is an FDA 510(k) premarket notification submitted by Biokit, S.A. for the device "ADVIA Centaur EBV-EBNA IgG". The FDA issued a decision of Substantially Equivalent on August 7, 2024. The device falls under product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Biokit, S.A. has at least 10 other 510(k) clearances on record.