510(k) K100525

ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 by Seppim S.A.S. — Product Code CGA

K100525 is an FDA 510(k) premarket notification submitted by Seppim S.A.S. for the device "ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2". The FDA issued a decision of Substantially Equivalent on December 15, 2010. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Seppim S.A.S. has at least 6 other 510(k) clearances on record.