TISSUE OF ORIGIN TEST KIT FFPE

TISSUE OF ORIGIN TEST KIT FFPE is an FDA 510(k)-cleared medical device (K120489) manufactured by Pathwork Diagnostics, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 16, 2012. Regulation: 8.