510(k) K953873

VARELISA HELICOBACTER PYLORI ANTIBODIES by Elias U.S.A., Inc. — Product Code LYR

K953873 is an FDA 510(k) premarket notification submitted by Elias U.S.A., Inc. for the device "VARELISA HELICOBACTER PYLORI ANTIBODIES". The FDA issued a decision of Substantially Equivalent on August 30, 1996. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Elias U.S.A., Inc. has at least 10 other 510(k) clearances on record.