510(k) K951206

VARELISA PARIETAL CELL ANTIBODIES by Elias U.S.A., Inc. — Product Code MLE

K951206 is an FDA 510(k) premarket notification submitted by Elias U.S.A., Inc. for the device "VARELISA PARIETAL CELL ANTIBODIES". The FDA issued a decision of Substantially Equivalent on April 17, 1995. The device falls under product code MLE (Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control), a Class II device regulated under 21 CFR 866.5110. Elias U.S.A., Inc. has at least 10 other 510(k) clearances on record.