De Novo
DEN230024: Technozym ADAMTS13 Activity
FDA De Novo · technoclone herstellung von diagnostika und arzneimitteln gm · decided Feb 28, 2024
Key facts
| De Novo number | DEN230024 |
|---|---|
| Device name | Technozym ADAMTS13 Activity |
| Applicant | technoclone herstellung von diagnostika und arzneimitteln gm |
| Product code | SAC |
| Date received | Apr 6, 2023 |
| Decision date | Feb 28, 2024 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Hematology |
| FEI number | 3003453957 |
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: