510(k) K964385

ELIAS ANA-HEP-2 by Elias U.S.A., Inc. — Product Code LJM

K964385 is an FDA 510(k) premarket notification submitted by Elias U.S.A., Inc. for the device "ELIAS ANA-HEP-2". The FDA issued a decision of Substantially Equivalent on March 6, 1997. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. Elias U.S.A., Inc. has at least 10 other 510(k) clearances on record.