De Novo
DEN190028: MyCare Psychiatry Clozapine Assay Kit
FDA De Novo · saladax biomedical inc · decided Apr 16, 2020
Key facts
| De Novo number | DEN190028 |
|---|---|
| Device name | MyCare Psychiatry Clozapine Assay Kit |
| Applicant | saladax biomedical inc |
| Product code | QKT |
| Date received | May 24, 2019 |
| Decision date | Apr 16, 2020 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Toxicology |
| FEI number | 3005567065 |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 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: