510(k) K930142

SYNELISA U1-SNRNP (68KDA)-ANTIBODIES by Elias U.S.A., Inc. — Product Code LKO

K930142 is an FDA 510(k) premarket notification submitted by Elias U.S.A., Inc. for the device "SYNELISA U1-SNRNP (68KDA)-ANTIBODIES". The FDA issued a decision of Substantially Equivalent on May 11, 1993. The device falls under product code LKO (Anti-Rnp Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Elias U.S.A., Inc. has at least 10 other 510(k) clearances on record.