De Novo
DEN230085: VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator
FDA De Novo · steris · decided Nov 12, 2024
Key facts
| De Novo number | DEN230085 |
|---|---|
| Device name | VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator |
| Applicant | steris |
| Product code | SDC |
| Date received | Dec 18, 2023 |
| Decision date | Nov 12, 2024 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General Hospital |
| FEI number | 3004080920 |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 UDI device identifiers (GUDID)
- 1–9 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: