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Seppim S.A.S.
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ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL is an FDA 510(k)-cleared medical device (K100547) manufactured by Seppim S.A.S.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 18, 2011. Regulation: 8.