510(k) K945607

VARELISA M2 ANTIBODIES by Elias U.S.A., Inc. — Product Code DBM

K945607 is an FDA 510(k) premarket notification submitted by Elias U.S.A., Inc. for the device "VARELISA M2 ANTIBODIES". The FDA issued a decision of Substantially Equivalent on January 24, 1995. The device falls under product code DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5090. Elias U.S.A., Inc. has at least 10 other 510(k) clearances on record.