510(k) K953632

SERIM PYLORITEK TEST KIT by Serim Research Corp. — Product Code LYR

K953632 is an FDA 510(k) premarket notification submitted by Serim Research Corp. for the device "SERIM PYLORITEK TEST KIT". The FDA issued a decision of Substantially Equivalent on December 18, 1995. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Serim Research Corp. has at least 10 other 510(k) clearances on record.