
Reference Diagnostics, Inc.
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TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET is an FDA 510(k)-cleared medical device (K052148) manufactured by Reference Diagnostics, Inc.. 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 November 8, 2005. Regulation: 8.