De Novo
DEN140001: ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT
FDA De Novo · kronus market development associates, inc. · decided Aug 20, 2014
Key facts
| De Novo number | DEN140001 |
|---|---|
| Device name | ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT |
| Applicant | kronus market development associates, inc. |
| Product code | PHF |
| Date received | Jun 16, 2014 |
| Decision date | Aug 20, 2014 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Immunology |
| FEI number | 2025560 |
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: