XW-100 Automated Hematology Analyzer, XW QC CHECK
FDA 510(k) clearance K143577 · decided 2015-10-12
Clearance details
- K-number
- K143577
- Device name
- XW-100 Automated Hematology Analyzer, XW QC CHECK
- Applicant
- Sysmex America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-12-17
- Decision date
- 2015-10-12
- Days to decision
- 299 days
- Clearance type
- Traditional
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Lincolnshire, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.