510(k) K110745

HELICOBACTER PYLORI ELISA IGG TEST KIT by Gold Standard Diagnostics — Product Code LYR

K110745 is an FDA 510(k) premarket notification submitted by Gold Standard Diagnostics for the device "HELICOBACTER PYLORI ELISA IGG TEST KIT". The FDA issued a decision of Substantially Equivalent on March 2, 2012. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Gold Standard Diagnostics has at least 10 other 510(k) clearances on record.