De Novo
DEN160003: Quantidex qPCR BCR-ABL IS Kit
FDA De Novo · asuragen, inc. · decided Jul 22, 2016
Key facts
| De Novo number | DEN160003 |
|---|---|
| Device name | Quantidex qPCR BCR-ABL IS Kit |
| Applicant | asuragen, inc. |
| Product code | OYX |
| Date received | Jan 19, 2016 |
| Decision date | Jul 22, 2016 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Pathology |
| FEI number | 3003436513 |
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: