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

K202304 is the FDA 510(k) clearance record for NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets), a class II device, cleared for Nyu Langone Medical Center on 2021-07-14 under FDA product code PZM (Next Generation Sequencing Based Tumor Profiling Test). FDA's definition for product code PZM reads: "A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from tumor specimens...". FDA records list one 510(k) clearance for Nyu Langone Medical Center. As of 2026-09-10, FDA records show no recalls naming K202304.