510(k) K875170

EBNA ANTIBODY by Hillcrest Biologicals — Product Code LLM

K875170 is an FDA 510(k) premarket notification submitted by Hillcrest Biologicals for the device "EBNA ANTIBODY". The FDA issued a decision of Substantially Equivalent on May 23, 1988. The device falls under product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Hillcrest Biologicals has at least 10 other 510(k) clearances on record.