SYSMEX XE-5000
FDA 510(k) clearance K071967 · decided 2007-11-20
Clearance details
- K-number
- K071967
- Device name
- SYSMEX XE-5000
- Applicant
- Sysmex America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-07-16
- Decision date
- 2007-11-20
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mundelein, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex recall (Z-0255-2013) | Sysmex America, Inc. | 2012-11-06 |