De Novo
DEN040003: GLUCATELL
FDA De Novo · associates of cape cod, inc. · decided May 21, 2004
Key facts
| De Novo number | DEN040003 |
|---|---|
| Device name | GLUCATELL |
| Applicant | associates of cape cod, inc. |
| Product code | NQZ |
| Date received | Mar 22, 2004 |
| Decision date | May 21, 2004 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Microbiology |
| FEI number | 1219145 |
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: