510(k) K161513

Anti-Borrelia burgdorferi US Westernblot (IgG) by Euroimmun US — Product Code LSR

K161513 is an FDA 510(k) premarket notification submitted by Euroimmun US for the device "Anti-Borrelia burgdorferi US Westernblot (IgG)". The FDA issued a decision of Substantially Equivalent on August 25, 2016. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Euroimmun US has at least 10 other 510(k) clearances on record.