
Kronus Market Development Associates, Inc.
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TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT is an FDA 510(k)-cleared medical device (K032134) manufactured by Kronus Market Development Associates, 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 September 9, 2003. Regulation: 8.