510(k) K951822

EBNA ENZYME IMMUNOASSAY KIT by Granbio, Inc. — Product Code LLM

K951822 is an FDA 510(k) premarket notification submitted by Granbio, Inc. for the device "EBNA ENZYME IMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on February 15, 1996. The device falls under product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Granbio, Inc. has at least 7 other 510(k) clearances on record.