De Novo
DEN040011: AMPLICHIP CYP450 TEST, MODEL 04381866190
FDA De Novo · roche molecular systems, inc. · decided Dec 23, 2004
Key facts
| De Novo number | DEN040011 |
|---|---|
| Device name | AMPLICHIP CYP450 TEST, MODEL 04381866190 |
| Applicant | roche molecular systems, inc. |
| Product code | NTI |
| Date received | Dec 20, 2004 |
| Decision date | Dec 23, 2004 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Toxicology |
| FEI number | 2243470 |
At a glance
- None 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: