Helix Laboratory Platform
De Novo DEN190035
Active
De Novo
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG | NumberDEN190035 | Date23 Dec 2020 | StatusActive |
Recalls
No FDA recalls found in the data synced 11 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- De Novo Number
- FDA Product Code
- QNC
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.6000
- Advisory Committee
- Medical Genetics
- FDA Decision
- DENG De Novo granted