The following data is part of a premarket notification filed by Nyu Langone Medical Center with the FDA for Nyu Langone Genome Pact (genome Profiling Of Actionable Cancer Targets).
| Device ID | K202304 |
| 510k Number | K202304 |
| Device Name: | NYU Langone Genome PACT (Genome Profiling Of Actionable Cancer Targets) |
| Classification | Next Generation Sequencing Based Tumor Profiling Test |
| Applicant | NYU Langone Medical Center 240 E 38th Street New York, NY 10016 |
| Contact | Matija Snuderl |
| Correspondent | Derek Symula New York State Department Of Health Wadsworth Center, Empire State Plaza P.O. Box 509 Albany, NY 12237 |
| Product Code | PZM |
| CFR Regulation Number | 866.6080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-08-14 |
| Decision Date | 2021-07-14 |