510(k) K883600

EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 by Clinical Sciences, Inc. — Product Code LLM

K883600 is an FDA 510(k) premarket notification submitted by Clinical Sciences, Inc. for the device "EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550". The FDA issued a decision of Substantially Equivalent on May 11, 1989. The device falls under product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Clinical Sciences, Inc. has at least 10 other 510(k) clearances on record.