Clearance Summary
NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) received FDA 510(k) clearance under submission number K202304, sponsored by Nyu Langone Medical Center. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2021-07-14.
- Submission: K202304
- Applicant / Sponsor: Nyu Langone Medical Center
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class II
- Regulation citation: 21 CFR 866.6080
- Decision date: 2021-07-14
Classification & Regulation
This clearance is catalogued under FDA product code PZM and 21 CFR 866.6080, within the Pathology review panel as a Class II device.