De Novo
DEN180056: GSP Neonatal Creatine Kinase - MM kit
FDA De Novo · perkinelmer inc. · decided Dec 12, 2019
Key facts
| De Novo number | DEN180056 |
|---|---|
| Device name | GSP Neonatal Creatine Kinase - MM kit |
| Applicant | perkinelmer inc. |
| Product code | QJE |
| Date received | Oct 11, 2018 |
| Decision date | Dec 12, 2019 |
| 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: