De Novo
DEN050002: LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
FDA De Novo · wako chemicals, usa, inc. · decided May 19, 2005
Key facts
| De Novo number | DEN050002 |
|---|---|
| Device name | LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS |
| Applicant | wako chemicals, usa, inc. |
| Product code | NSF |
| Date received | Apr 7, 2005 |
| Decision date | May 19, 2005 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Immunology |
At a glance
- None 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: