De Novo
DEN130005: QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS
FDA De Novo · centers for disease control and prevention · decided Aug 8, 2013
Key facts
| De Novo number | DEN130005 |
|---|---|
| Device name | QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS |
| Applicant | centers for disease control and prevention |
| Product code | PDY |
| Date received | May 28, 2013 |
| Decision date | Aug 8, 2013 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Toxicology |
| FEI number | 1050190 |
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: