Leica Biosystems Imaging, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 3
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0046-2020 | Class II | Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE. | December 10, 2018 |
| Z-1152-2014 | Class II | HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue | February 7, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232202 | Aperio GT 450 DX | April 16, 2024 |
| K190332 | Aperio AT2 DX System | May 20, 2019 |
| K141109 | APERIO EPATHOLOGY EIHC IVD SYSTEM | July 29, 2014 |