De Novo
DEN160001: BD MAX Vaginal Panel, BD MAX Instrument
FDA De Novo · geneohm sciences canada, inc (bd diagnostics) · decided Oct 28, 2016
Key facts
| De Novo number | DEN160001 |
|---|---|
| Device name | BD MAX Vaginal Panel, BD MAX Instrument |
| Applicant | geneohm sciences canada , inc (bd diagnostics) |
| Product code | PQA |
| Date received | Jan 11, 2016 |
| Decision date | Oct 28, 2016 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Microbiology |
| FEI number | 1119779 |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- None UDI device identifiers (GUDID)
- 10–99 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: