De Novo
DEN030002: ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
FDA De Novo · spectral diagnostics, inc. · decided Jun 16, 2003
Key facts
| De Novo number | DEN030002 |
|---|---|
| Device name | ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE |
| Applicant | spectral diagnostics, inc. |
| Product code | NGS |
| Date received | Apr 14, 2003 |
| Decision date | Jun 16, 2003 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Microbiology |
At a glance
- 1–9 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: