Cellavision AB
FDA Regulatory Profile
Cellavision AB appears in FDA public data with 2 recalls, 7 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0542-2026, Class II) was initiated on Oct 8, 2025. Its most recent 510(k) clearance was granted on Oct 16, 2020.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 7
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0542-2026 | Class II | REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with | Oct 8, 2025 |
| Z-2184-2018 | Class II | CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM9 | Dec 4, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K200595 | CellaVision DC-1, CellaVision DC-1 PPA | Oct 16, 2020 |
| K171315 | Advanced RBC Application | Aug 1, 2017 |
| K102778 | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION | Sep 16, 2011 |
| K092868 | CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 | Nov 20, 2009 |
| K080595 | CELLAVISION DM96 WITH THE BODY FLUID APPLICATION | Dec 5, 2008 |
| K033840 | CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER | Feb 10, 2004 |
| K003301 | DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER | Mar 15, 2001 |