510(k) K181329

EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay by Phadia AB — Product Code MSV

K181329 is an FDA 510(k) premarket notification submitted by Phadia AB for the device "EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay". The FDA issued a decision of Substantially Equivalent on June 25, 2018. The device falls under product code MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)), a Class II device regulated under 21 CFR 866.5660. Phadia AB has at least 10 other 510(k) clearances on record.