De Novo
DEN000007: QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
FDA De Novo · inova diagnostics, inc. · decided Aug 16, 2000
Key facts
| De Novo number | DEN000007 |
|---|---|
| Device name | QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA |
| Applicant | inova diagnostics, inc. |
| Product code | NBT |
| Date received | Jul 18, 2000 |
| Decision date | Aug 16, 2000 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Immunology |
| FEI number | 2026994 |
At a glance
- None Later 510(k)s citing this De Novo
- 100–999 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: