De Novo
DEN170029: PrimeStore MTM
FDA De Novo · longhorn vaccines and diagnostics llc · decided Mar 19, 2018
Key facts
| De Novo number | DEN170029 |
|---|---|
| Device name | PrimeStore MTM |
| Applicant | longhorn vaccines and diagnostics llc |
| Product code | QBD |
| Date received | May 24, 2017 |
| Decision date | Mar 19, 2018 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Microbiology |
| FEI number | 3011818318 |
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: