510(k) K172722

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) by Euroimmun Us, Inc. — Product Code LSR

K172722 is an FDA 510(k) premarket notification submitted by Euroimmun Us, Inc. for the device "Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)". The FDA issued a decision of Substantially Equivalent on December 10, 2017. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Euroimmun Us, Inc. has at least 10 other 510(k) clearances on record.