510(k) K980598

EBNA-1 IGM ELISA TEST SYSTEM by Clark Laboratories, Inc. — Product Code LLM

K980598 is an FDA 510(k) premarket notification submitted by Clark Laboratories, Inc. for the device "EBNA-1 IGM ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on May 1, 1998. The device falls under product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Clark Laboratories, Inc. has at least 10 other 510(k) clearances on record.