Leica Biosystems Newcastle Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 3
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0717-2014 | Class II | Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle | July 31, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K213348 | BOND MMR Antibody Panel | February 21, 2023 |
| K193393 | BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal An | March 6, 2020 |
| K122556 | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) | May 19, 2014 |