De Novo
DEN180004: picoAMH ELISA
FDA De Novo · ansh labs llc · decided Oct 24, 2018
Key facts
| De Novo number | DEN180004 |
|---|---|
| Device name | picoAMH ELISA |
| Applicant | ansh labs llc |
| Product code | QDH |
| Date received | Jan 22, 2018 |
| Decision date | Oct 24, 2018 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Chemistry |
| FEI number | 3008198807 |
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: