510(k) K161139

LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set by DiaSorin, Inc. — Product Code LYR

K161139 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set". The FDA issued a decision of Substantially Equivalent on July 22, 2016. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.