510(k) K113020

IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS by Immco Diagnostics, Inc. — Product Code MID

K113020 is an FDA 510(k) premarket notification submitted by Immco Diagnostics, Inc. for the device "IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS". The FDA issued a decision of Substantially Equivalent on October 25, 2012. The device falls under product code MID (System, Test, Anticardiolipin Immunological), a Class II device regulated under 21 CFR 866.5660. Immco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.