De Novo
DEN220027: B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System
FDA De Novo · brahms gmbh, part of thermo fisher scientific · decided May 18, 2023
Key facts
| De Novo number | DEN220027 |
|---|---|
| Device name | B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System |
| Applicant | brahms gmbh, part of thermo fisher scientific |
| Product code | QWH |
| Date received | May 2, 2022 |
| Decision date | May 18, 2023 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Toxicology |
| FEI number | 3003561301 |
At a glance
- 1–9 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: