De Novo
DEN990008: WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000
FDA De Novo · wallac, inc. · decided Feb 15, 2000
Key facts
| De Novo number | DEN990008 |
|---|---|
| Device name | WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 |
| Applicant | wallac, inc. |
| Product code | NAK |
| Date received | Dec 20, 1999 |
| Decision date | Feb 15, 2000 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Chemistry |
| FEI number | 3002808498 |
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: