FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sysmex XW-100 Automated Hematology Analyzer
K Number: K210346
·
Decision Nov 8, 2022
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
376
Applicant Total
1
Review Days
638
Basic Information
- Device Name
- Sysmex XW-100 Automated Hematology Analyzer
- K Number
- K210346
- Device Class
- FDA class 2
- Clearance Type
- Dual Track
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sysmex America, INC.
- Date Received
- February 8, 2021
- Decision Date
- November 8, 2022
- Product Code
- GKZ
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GKZ | Counter, Differential Cell | FDA class 2 | Hematology |
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