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Advanced Diagnostic Systems
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CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM is an FDA 510(k)-cleared medical device (DEN040001) manufactured by Advanced Diagnostic Systems. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 20, 2004. Regulation: 8.