De Novo
DEN170058: MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay
FDA De Novo · memorial sloan-kettering cancer center · decided Nov 15, 2017
Key facts
| De Novo number | DEN170058 |
|---|---|
| Device name | MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay |
| Applicant | memorial sloan-kettering cancer center |
| Product code | PZM |
| Date received | Sep 25, 2017 |
| Decision date | Nov 15, 2017 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Pathology |
| FEI number | 3014491911 |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: