NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)

NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) is an FDA 510(k)-cleared medical device (K202304) manufactured by Nyu Langone Medical Center. This device is classified under the Pathology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 13, 2021. Regulation: 8.