De Novo
DEN140002: EUROIMMUN ANTI-PLA2R IFA
FDA De Novo · euroimmun us · decided May 29, 2014
Key facts
| De Novo number | DEN140002 |
|---|---|
| Device name | EUROIMMUN ANTI-PLA2R IFA |
| Applicant | euroimmun us |
| Product code | PGV |
| Date received | Mar 28, 2014 |
| Decision date | May 29, 2014 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Immunology |
| FEI number | 3007118747 |
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: