510(k) K173496

Sofia 2 Lyme FIA, Sofia Lyme Control Set by Quidel Corporation — Product Code LSR

K173496 is an FDA 510(k) premarket notification submitted by Quidel Corporation for the device "Sofia 2 Lyme FIA, Sofia Lyme Control Set". The FDA issued a decision of Substantially Equivalent on August 30, 2018. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Quidel Corporation has at least 10 other 510(k) clearances on record.