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Seppim S.A.S.
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ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS is an FDA 510(k)-cleared medical device (K100263) manufactured by Seppim S.A.S.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 5, 2011. Regulation: 8.