FDA Product Code
FDA Product Code SEP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.2920
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260184 | Onclarity Self-Collection Kit | Becton, Dickinson and Company | 2026-04-02 | Traditional | PDF ↗ |
| DEN240045 | Teal Wand | Teal Health, Inc. | 2025-05-09 | Direct | — |
Product code SEP · Class II · Microbiology. Data: openFDA.