510(k) K915185

GAP IGG H.PYLORI MODIFIED by Biomerica, Inc. — Product Code LYR

K915185 is an FDA 510(k) premarket notification submitted by Biomerica, Inc. for the device "GAP IGG H.PYLORI MODIFIED". The FDA issued a decision of Substantially Equivalent on March 4, 1992. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Biomerica, Inc. has at least 9 other 510(k) clearances on record.