De Novo
DEN120013: PORTRAIT ANALYZER
FDA De Novo · great basin scientific · decided Apr 30, 2012
Key facts
| De Novo number | DEN120013 |
|---|---|
| Device name | PORTRAIT ANALYZER |
| Applicant | great basin scientific |
| Product code | OMN |
| Date received | Mar 2, 2012 |
| Decision date | Apr 30, 2012 |
| Decision | granted (DENG) |
| FDA classification | Class I |
| Review panel | Microbiology |
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: