De Novo
BR220665: Hemanext ONE
FDA De Novo · Hemanext, Inc. · decided Sep 15, 2023
Key facts
| De Novo number | BR220665 |
|---|---|
| Device name | Hemanext ONE |
| Applicant | Hemanext, Inc. |
| Product code | QYC |
| Date received | Jan 5, 2022 |
| Decision date | Sep 15, 2023 |
| Decision | Granted - Direct De Novo |
| FDA classification | Class II |
| Review panel | Hematology |
| FEI number | 3044771515 |
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: