MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT

MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT is an FDA 510(k)-cleared medical device (K052191) manufactured by Veridex, LLC. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 2005. Regulation: 8.