De Novo
DEN200059: POMC/PCSK1/LEPR CDx Panel
FDA De Novo · preventiongenetics, llc · decided Jan 21, 2022
Key facts
| De Novo number | DEN200059 |
|---|---|
| Device name | POMC/PCSK1/LEPR CDx Panel |
| Applicant | preventiongenetics, llc |
| Product code | QRV |
| Date received | Sep 18, 2020 |
| Decision date | Jan 21, 2022 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Chemistry |
At a glance
- None Later 510(k)s citing this De Novo
- None 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: