510(k) K053335

PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 by Meridian Bioscience, Inc. — Product Code LYR

K053335 is an FDA 510(k) premarket notification submitted by Meridian Bioscience, Inc. for the device "PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480". The FDA issued a decision of Substantially Equivalent on March 10, 2006. 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.