De Novo
DEN170019: Vitamin D 200M Assay for the Topaz System
FDA De Novo · ab sciex llc · decided May 18, 2017
Key facts
| De Novo number | DEN170019 |
|---|---|
| Device name | Vitamin D 200M Assay for the Topaz System |
| Applicant | ab sciex llc |
| Product code | PSL |
| Date received | Mar 20, 2017 |
| Decision date | May 18, 2017 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Chemistry |
| FEI number | 3008336863 |
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: