
Union Carbide Corp.
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CENTRIFICHEM COMB. SERUM-BASED CALIB. is an FDA 510(k)-cleared medical device (K802741) manufactured by Union Carbide Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 9, 1980. Regulation: 8.