510(k) K953587

VARELISA MPO-ANCA by Elias U.S.A., Inc. — Product Code MOB

K953587 is an FDA 510(k) premarket notification submitted by Elias U.S.A., Inc. for the device "VARELISA MPO-ANCA". The FDA issued a decision of Substantially Equivalent on January 26, 1996. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Elias U.S.A., Inc. has at least 10 other 510(k) clearances on record.