510(k) K163713

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

K163713 is an FDA 510(k) premarket notification submitted by Quidel Corporation for the device "Sofia Lyme FIA, Sofia Lyme Control Set". The FDA issued a decision of Substantially Equivalent on October 20, 2017. 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.