De Novo
DEN130042: MISEQDX UNIVERSAL KIT 1.0
FDA De Novo · illumina, inc. · decided Nov 19, 2013
Key facts
| De Novo number | DEN130042 |
|---|---|
| Device name | MISEQDX UNIVERSAL KIT 1.0 |
| Applicant | illumina, inc. |
| Product code | PFT |
| Date received | Oct 4, 2013 |
| Decision date | Nov 19, 2013 |
| Decision | granted (DENG) |
| FDA classification | Class I |
| Review panel | Clinical Toxicology |
| FEI number | 3003218906 |
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: