De Novo
DEN080007: ALLOMAP MOLECULAR EXPRESSION TESTING
FDA De Novo · xdx · decided Aug 26, 2008
Key facts
| De Novo number | DEN080007 |
|---|---|
| Device name | ALLOMAP MOLECULAR EXPRESSION TESTING |
| Applicant | xdx |
| Product code | OJQ |
| Date received | Aug 15, 2008 |
| Decision date | Aug 26, 2008 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Chemistry |
| FEI number | 3005225997 |
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: