De Novo
DEN000010: TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
FDA De Novo · biosite incorporated · decided Nov 20, 2000
Key facts
| De Novo number | DEN000010 |
|---|---|
| Device name | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST |
| Applicant | biosite incorporated |
| Product code | NBC |
| Date received | Nov 15, 2000 |
| Decision date | Nov 20, 2000 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Chemistry |
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: