510(k) K141375

ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 by Phadia US, Inc. — Product Code DBM

K141375 is an FDA 510(k) premarket notification submitted by Phadia US, Inc. for the device "ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250". The FDA issued a decision of Substantially Equivalent on February 13, 2015. The device falls under product code DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5090. Phadia US, Inc. has at least 10 other 510(k) clearances on record.