Earlitec Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 4
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253442 | EarliPoint Assessment | March 5, 2026 |
| K243891 | EarliPoint System | March 26, 2025 |
| K230337 | EarliPoint | June 29, 2023 |
| K213882 | EarliPoint System | June 8, 2022 |