De Novo
DEN170010: LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
FDA De Novo · lin-zhi international, inc. · decided Apr 20, 2018
Key facts
| De Novo number | DEN170010 |
|---|---|
| Device name | LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay |
| Applicant | lin-zhi international, inc. |
| Product code | QBK |
| Date received | Feb 21, 2017 |
| Decision date | Apr 20, 2018 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Toxicology |
| FEI number | 3003610499 |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- 10–99 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: