Meridian Bioscience Israel , Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K221896 | BreathID Hp System | December 19, 2022 |
| K223185 | BreathID® Smart System | November 10, 2022 |
| K220494 | BreathID Hp Lab System, BreathID Smart System | June 23, 2022 |