510(k) K935730

EBNA IGG ELISA TEST by Gull Laboratories, Inc. — Product Code LLM

K935730 is an FDA 510(k) premarket notification submitted by Gull Laboratories, Inc. for the device "EBNA IGG ELISA TEST". The FDA issued a decision of Substantially Equivalent on September 19, 1995. The device falls under product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Gull Laboratories, Inc. has at least 10 other 510(k) clearances on record.