CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
FDA 510(k) clearance K092868 · decided 2009-11-20
Clearance details
- K-number
- K092868
- Device name
- CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
- Applicant
- CellaVision AB
- Decision
- Substantially Equivalent
- Date received
- 2009-09-18
- Decision date
- 2009-11-20
- Days to decision
- 63 days
- Clearance type
- Special
- Product code
- JOY
- Device class
- 2
- Regulation number
- 864.5260
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Fridley, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunc recall (Z-0542-2026) | Cellavision AB | 2025-11-18 |