De Novo
DEN150057: Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
FDA De Novo · roche diagnostics · decided Dec 19, 2016
Key facts
| De Novo number | DEN150057 |
|---|---|
| Device name | Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 |
| Applicant | roche diagnostics |
| Product code | PQO |
| Date received | Dec 9, 2015 |
| Decision date | Dec 19, 2016 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Toxicology |
| FEI number | 3002806560 |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- 1–9 UDI device identifiers (GUDID)
- 10–99 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: