510(k) K110899

GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT by Gold Standard Diagnostics — Product Code LYR

K110899 is an FDA 510(k) premarket notification submitted by Gold Standard Diagnostics for the device "GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT". The FDA issued a decision of Substantially Equivalent on February 1, 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.