De Novo
DEN160033: ARK Voriconazole II Assay Test System
FDA De Novo · ark diagnostics, inc · decided May 5, 2017
Key facts
| De Novo number | DEN160033 |
|---|---|
| Device name | ARK Voriconazole II Assay Test System |
| Applicant | ark diagnostics, inc |
| Product code | PUJ |
| Date received | Jul 15, 2016 |
| Decision date | May 5, 2017 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Toxicology |
| FEI number | 3005755244 |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 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: