De Novo
DEN130002: TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
FDA De Novo · roche diagnostics · decided May 23, 2013
Key facts
| De Novo number | DEN130002 |
|---|---|
| Device name | TINA-QUANT HBA1C GEN. 2 TEST SYSTEM |
| Applicant | roche diagnostics |
| Product code | PDJ |
| Date received | Mar 25, 2013 |
| Decision date | May 23, 2013 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Chemistry |
| FEI number | 3002806560 |
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: