De Novo
DEN130011: ILLUMINA MISEQDX PLATFORM
FDA De Novo · illumina, inc. · decided Nov 19, 2013
Key facts
| De Novo number | DEN130011 |
|---|---|
| Device name | ILLUMINA MISEQDX PLATFORM |
| Applicant | illumina, inc. |
| Product code | PFF |
| Date received | Sep 23, 2013 |
| Decision date | Nov 19, 2013 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Toxicology |
| FEI number | 3003218906 |
At a glance
- 1–9 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: