NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
FDA 510(k) clearance K202304 · decided 2021-07-14
Clearance details
- K-number
- K202304
- Device name
- NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
- Applicant
- Nyu Langone Medical Center
- Decision
- Substantially Equivalent
- Date received
- 2020-08-14
- Decision date
- 2021-07-14
- Days to decision
- 334 days
- Clearance type
- Traditional
- Product code
- PZM
- Device class
- 2
- Regulation number
- 866.6080
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- New York, NY, US
- Third-party review
- Yes
- Expedited review
- No
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| CellDx-Tissue (K260235) | Datar Cancer Genetics Private Limited | 2026-05-12 |
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| PGDx elio tissue complete (K192063) | Personal Genome Diagnostics | 2020-04-24 |
| Omics Core (K190661) | Nanthealth, Inc. | 2019-11-09 |
| MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay (DEN170058) | Memorial Sloan-Kettering Cancer Center | 2017-11-15 |
Recalls involving this device
No recalls on record reference this clearance.