FDA Product Code
FDA Product Code SBY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Pathology
- 21 CFR Citation
- 866.6085
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN230046 | PGDx elio plasma focus Dx | Personal Genome Diagnostics, Inc. | 2024-08-01 | Direct | — |
Product code SBY · Class II · Pathology. Data: openFDA.