Next Generation Sequencing Based Tumor Profiling Test
Regulation 866.6080
1510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PZM
| Company | 510(k)s | Recalls |
|---|---|---|
| Act Genomics | 1 | 0 |
| Datar Cancer Genetics Private Limited | 1 | 0 |
| Geneseeq Technology, Inc. | 1 | 0 |
| Memorial Sloan-Kettering Cancer Center | 1 | 0 |
| Nanthealth, Inc. | 1 | 0 |
| Nyu Langone Medical Center | 1 | 0 |
| Personal Genome Diagnostics | 1 | 0 |
| Tempus AI, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 12, 2026 | K260235 | CellDx-Tissue Datar Cancer Genetics Private Limited, IN | PZM |
| Sep 19, 2025 | K241868 | xR IVD Tempus AI, Inc. | PZM |
| Aug 29, 2025 | K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) Geneseeq Technology, Inc., CA | PZM |
| Dec 23, 2022 | K210017 | ACTOnco, ACTOnco IVD Act Genomics, TW | PZM |
| Jul 14, 2021 | K202304 | NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) Nyu Langone Medical Center | PZM |
| Apr 24, 2020 | K192063 | PGDx elio tissue complete Personal Genome Diagnostics | PZM |
| Nov 9, 2019 | K190661 | Omics Core Nanthealth, Inc. | PZM |
| Nov 15, 2017 | DEN170058 | MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Se Memorial Sloan-Kettering Cancer Center | PZM |
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