510(k) K973941

IMMUNOWELL EBNA IGG TEST by Genbio — Product Code LLM

K973941 is an FDA 510(k) premarket notification submitted by Genbio for the device "IMMUNOWELL EBNA IGG TEST". The FDA issued a decision of Substantially Equivalent on August 10, 1998. The device falls under product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Genbio has at least 9 other 510(k) clearances on record.