FDA Product Code
FDA Product Code QYV — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Pathology
- 21 CFR Citation
- 864.3900
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN210035 | Genius Digital Diagnostics System with the Genius Cervical AI algorithm | Hologic, Inc. | 2024-01-31 | Direct | — |
Product code QYV · Class II · Pathology. Data: openFDA.