510(k) K930422

SYNELISA PARIETAL CELL ANTIBODIES by Elias U.S.A., Inc. — Product Code DBJ

K930422 is an FDA 510(k) premarket notification submitted by Elias U.S.A., Inc. for the device "SYNELISA PARIETAL CELL ANTIBODIES". The FDA issued a decision of Substantially Equivalent on August 3, 1993. The device falls under product code DBJ (Antiparietal Antibody, Indirect Immunofluorescent, 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.