510(k) K103376

ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL by Seppim S.A.S. — Product Code JFY

K103376 is an FDA 510(k) premarket notification submitted by Seppim S.A.S. for the device "ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL". The FDA issued a decision of Substantially Equivalent on November 18, 2011. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Seppim S.A.S. has at least 6 other 510(k) clearances on record.