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BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 2
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1233-2025 | Class II | DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software. | January 10, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K221114 | Immunoglobulin G (IgG) | August 2, 2023 |
| K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer | July 20, 2023 |