510(k) K930143

AYNELISA M2-ANTIBODIES by Elias U.S.A., Inc. — Product Code DBM

K930143 is an FDA 510(k) premarket notification submitted by Elias U.S.A., Inc. for the device "AYNELISA M2-ANTIBODIES". The FDA issued a decision of Substantially Equivalent on May 11, 1993. The device falls under product code DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5090. Elias U.S.A., Inc. has at least 10 other 510(k) clearances on record.