
Sweden Diagnostics (Us), Inc.
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ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 is an FDA 510(k)-cleared medical device (K061165) manufactured by Sweden Diagnostics (Us), Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 2, 2006. Regulation: 8.