510(k) K840417

EBNA ACIF KIT by Litton Bionetics — Product Code LLM

K840417 is an FDA 510(k) premarket notification submitted by Litton Bionetics for the device "EBNA ACIF KIT". The FDA issued a decision of Substantially Equivalent on December 27, 1984. The device falls under product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Litton Bionetics has at least 10 other 510(k) clearances on record.