De Novo
DEN060007: INTROL CF PANEL I CONTROL
FDA De Novo · maine molecular quality controls, inc. · decided Oct 12, 2006
Key facts
| De Novo number | DEN060007 |
|---|---|
| Device name | INTROL CF PANEL I CONTROL |
| Applicant | maine molecular quality controls, inc. |
| Product code | NZB |
| Date received | Aug 14, 2006 |
| Decision date | Oct 12, 2006 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Immunology |
| FEI number | 3005959679 |
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: