510(k) K211342

Sofia 2 Campylobacter FIA by Quidel Corporation — Product Code LQP

K211342 is an FDA 510(k) premarket notification submitted by Quidel Corporation for the device "Sofia 2 Campylobacter FIA". The FDA issued a decision of Substantially Equivalent on November 23, 2021. The device falls under product code LQP (Campylobacter Spp.), a Class I device regulated under 21 CFR 866.3110. Quidel Corporation has at least 10 other 510(k) clearances on record.