510(k) K100547

ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL by Seppim S.A.S. — Product Code LCP

K100547 is an FDA 510(k) premarket notification submitted by Seppim S.A.S. for the device "ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL". The FDA issued a decision of Substantially Equivalent on May 19, 2011. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Seppim S.A.S. has at least 6 other 510(k) clearances on record.