The following data is part of a De Novo classification by Memorial Sloan-kettering Cancer Center with the FDA for Msk-impact (integrated Mutation Profiling Of Actionable Cancer Targets):a Hybridization-capture Based Next Generation Sequencing Assay.
| DeNovo ID | DEN170058 |
| Device Name: | MSK-IMPACT (Integrated Mutation Profiling Of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay |
| Classification | Next Generation Sequencing Based Tumor Profiling Test |
| Applicant | Memorial Sloan-Kettering Cancer Center department Of Pathology 444 E 68th Street H505 New York, NY 10065 |
| Contact | Christine England |
| Product Code | PZM |
| CFR Regulation Number | 866.6080 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Pathology |
| Classification Advisory | Pathology |
| Type | Direct |
| Date Received | 2017-09-25 |
| Decision Date | 2017-11-15 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |