510(k) K930002

ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA by Ortho Diagnostic Systems, Inc. — Product Code LLM

K930002 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA". The FDA issued a decision of Substantially Equivalent on July 16, 1993. The device falls under product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Ortho Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.