510(k) K192817

Curian HpSA, Curian Analyzer by Meridian Bioscience, Inc. — Product Code LYR

K192817 is an FDA 510(k) premarket notification submitted by Meridian Bioscience, Inc. for the device "Curian HpSA, Curian Analyzer". The FDA issued a decision of Substantially Equivalent on March 13, 2020. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Meridian Bioscience, Inc. has at least 10 other 510(k) clearances on record.