510(k) K093883

AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- by Seppim S.A.S. — Product Code CIT

K093883 is an FDA 510(k) premarket notification submitted by Seppim S.A.S. for the device "AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-". The FDA issued a decision of Substantially Equivalent on September 20, 2010. The device falls under product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Seppim S.A.S. has at least 6 other 510(k) clearances on record.